Alto Development Corp

Farmingdale, NJ, US

ALTO DEVELOPMENT CORP. appears in FDA device records in Farmingdale, NJ. FDA records list 12 510(k) clearances between 1982-07-08 and 2008-04-29, no PMA records and one registered establishment. As of 2026-09-10, FDA records show 8 recalls for this company, and at least one establishment registration is current.

510(k) clearances: 12
PMA records: 0
Recall records: 8
Registered establishments: 1

FDA records under these names

1 name

FDA records resolved to Alto Development Corp carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

European Custom Manufacturing BV510(k), recall

510(k) clearance history

FDA records hold 12 510(k) clearances for Alto Development Corp between 1982 and 2008. The busiest year on record is 1988, with 2. The most recent is 2008, with 1.

Clearances by year, as a table

510(k) clearance decisions for Alto Development Corp, by decision year
Year	Clearances
1982	1
1983	1
1988	2
1992	2
1993	2
1994	1
1996	1
2004	1
2008	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K080621	FASTLOCK, MODEL PC175M01, PC175MCE, PC005R01	DSA	Substantially Equivalent	2008-04-29
K033858	TEMPORARY BIPOLAR MYOCARDIAL PACING WIRE	LDF	Substantially Equivalent	2004-07-12
K964621	A & E MEDICAL ELECTROCAUTERY SUCTION TUBE WITH FINGER TIP ACTIVATOR BUTTON	GEI	Substantially Equivalent	1996-12-20
K932513	LABELING FOR MYO/WIRE II STERNOTOMY SUTURES	GAO	Substantially Equivalent	1994-01-07
K931537	A&E MEDICAL ELECTROSURG ELECTRO W/NON-STICK COAT	GEI	Substantially Equivalent	1993-09-07
K930528	A&E MEDICAL ELECTROSURGICAL CONNECTING CORDS	GEI	Substantially Equivalent	1993-05-17
K914193	A&E MEDICAL CORP DISPOS SUCT COAG W/NON STICK COAT	GEI	Substantially Equivalent	1992-10-05
K915300	A & EM MEDICAL ELECTROSURGICAL PENCIL/ACCESSORIES	GEI	Substantially Equivalent	1992-02-18
K884783	RANEY CLIP	FZQ	Substantially Equivalent	1988-11-30
K881413	ELECTRO-CAUTERY SUCTION TUBE	GEI	Substantially Equivalent	1988-04-21
K831867	PRESSURE MONITORING IV BOTTLE CAP	DRS	Substantially Equivalent	1983-08-12
K821518	MYO/CLIP	LDF	Substantially Equivalent	1982-07-08

Registered establishments

FDA registered establishments for Alto Development Corp, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
2242056	2242056	ALTO DEVELOPMENT CORP.	5206 Asbury Road, FARMINGDALE, NJ 07727 US	2026	GAO GAQ GEI HRS HTZ HWC HXS IKD JDQ LDF and 3 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-0246-2020	A&E Medical Thorecon Plating System Kits Model No. 94-1700-10. For fracture fixation or reconstruction of the sternum.	Some Thorecon disposable tensioners supplied in different Plating System Kits exhibit a molding defect which occludes the through-channel for cable tensioning, rendering the tensioner inoperable.	Class II	2019-09-10	Terminated
Z-0245-2020	A&E Medical Thorecon Plating System Kits Model No. 94-1500-04-S. For fracture fixation or reconstruction of the sternum.	Some Thorecon disposable tensioners supplied in different Plating System Kits exhibit a molding defect which occludes the through-channel for cable tensioning, rendering the tensioner inoperable.	Class II	2019-09-10	Terminated
Z-0244-2020	A&E Medical Thorecon Plating System Kits Model No. 94-1400-04. For fracture fixation or reconstruction of the sternum.	Some Thorecon disposable tensioners supplied in different Plating System Kits exhibit a molding defect which occludes the through-channel for cable tensioning, rendering the tensioner inoperable.	Class II	2019-09-10	Terminated
Z-0243-2020	A&E Medical Thorecon Plating System Kits Model No. 94-1300-04-S. For fracture fixation or reconstruction of the sternum.	Some Thorecon disposable tensioners supplied in different Plating System Kits exhibit a molding defect which occludes the through-channel for cable tensioning, rendering the tensioner inoperable.	Class II	2019-09-10	Terminated
Z-0242-2020	A&E Medical Thorecon Plating System Kits Model No. 94-1200-08. For fracture fixation or reconstruction of the sternum.	Some Thorecon disposable tensioners supplied in different Plating System Kits exhibit a molding defect which occludes the through-channel for cable tensioning, rendering the tensioner inoperable.	Class II	2019-09-10	Terminated
Z-2098-2019	A&E Medical Corp. Ultra-Flex MYO/Wire Ultra-Flex Monopolar Pacing Wire Looped Electrode (M-21 SERIES)- Temporary Pacing Electrode as follows: 021-001 MYO/Wire Ultra-Flex Monopolar (Wht.,2-0) 021-010 MYO/Wire Ultra-Flex Monopolar (Org.,2-0) 021-011 MYO/Wire Ultra-Flex Monopolar (Wht.,2-0) Used as a connection between temporary cardiac pacing or monitoring equipment and the heart.	Updated instructions for use: Ultra-Flex MYO/WIRE Monopolar pacing wire looped electrode (M-21 Series) to be consistent between electrode IFU and instructions for M-21 loop.	Class II	2019-06-21	Terminated
Z-0813-2018	Surgical punch; sealed pouches packed in punch shelf box Intended for use by trained surgeons to create circular cuts in soft tissue or openings in soft vessel walls during surgical procedures.	Surgical punches are being recalled due to potential packaging damage which may have occurred during transportation resulting in loss of sterility.	Class II	2017-10-23	Terminated
Z-1038-2012	Temporary Pacing Wire, BIPOLAR, Models BM, V, VE and VF, Rx Only, STERILE/EO, Single use only -- Mce (MEDICAL CONCEPTS EUROPE) --- Manufacturer ECM B.V. Oost-Om 54, P.O. Box 53, NL 5420 AB GEMERT --- Shipping or Unit Package: 20 individual units packaged per box with 6 boxes per case. --- Device Classification Name: Electrode, pacemaker, temporary. ---The device is supplied sterile and intended for single use. Used to pace the heart during or after open heart surgery. The electrodes are placed on the heart; the other end of the pacing wire is inserted through the skin of the patient with a thoracic needle. The thoracic needle can snap-off at the end where the pacing wire is attached, after snap-off the remaining pins are connected to an external pacemaker. For temporary atrial and ventrical pacing and sensing for contemplated implant duration of 7 days or less.	The crimping operation during product production was not performed properly. As such, the pacing wire may separate from the connection pin, which causes non-functionality.		2011-04-18	Terminated

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain