510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN

Engineered Medical Systems, LLC

Indianapolis, IN, US

Engineered Medical Systems, LLC appears in FDA device records in Indianapolis, IN. FDA records list 25 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
25
PMA records
0
Recall records
1
Registered establishments
2

FDA records under these names

1 name

FDA records resolved to Engineered Medical Systems, LLC 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.

  • Pulmodyne Inc.registration, 510(k)

510(k) clearance history

FDA records hold 25 510(k) clearances for Engineered Medical Systems, LLC between 1987 and 2022. The busiest year on record is 1993, with 5. The most recent is 2022, with 1.

Clearances by year, as a table
510(k) clearance decisions for Engineered Medical Systems, LLC, by decision year
YearClearances
19872
19912
19935
19981
19994
20003
20024
20031
20071
20081
20221
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K220533Endoscopy Oxygen MaskCCKSubstantially Equivalent
K080256PULMODYNE CHF FLOW GENERATOR SYSTEMBYESubstantially Equivalent
K062104TALKING TRACHBTOSubstantially Equivalent
K023683MULTI-STRAP FULL FACE MASKBZDSubstantially Equivalent
K013728TRACH VOXJOHSubstantially Equivalent
K013122EMS ELECTROSTATIC FLITER AND HME COMBINATIONCAHSubstantially Equivalent
K013123EMS PULMONARY FUNCTION TESTING FILTERBZGSubstantially Equivalent
K013089EMS HEPA FILTER AND HME COMBINATIONSCAHSubstantially Equivalent
K003497DISPOSABLE PRESSURE MONITORCAPSubstantially Equivalent
K000215SWIVEL ELBOWBZDSubstantially Equivalent
K000314INCENTIVE SPIROMETERBWFSubstantially Equivalent
K991955MODIFICATION TO ENGINEERED MEDICAL SYSTEMS DISPOSABLE MANUAL RESUSCITATOR WITH CO2 DETECTIONBTMSubstantially Equivalent
K991953MODIFICATION TO ENGINEERED MEDICAL SYSTEMS DISPOSABLE MANUAL RESUSCITATOR WITH CO2 DETECTIONBTMSubstantially Equivalent
K983919EMS MOUTH TO MASK RESUSCITATORSCBPSubstantially Equivalent
K983920EMS PEEP VALVES- ADJUSTABLEBYESubstantially Equivalent
K972605EMS NASAL CPAP MASKBZDSubstantially Equivalent
K932799SINGLE USE MANUAL RESUSCITATOR PEEP VALVEBYESubstantially Equivalent
K932797PRESSURE LIMITING ELBOWBTMSubstantially Equivalent
K930083EMS BIOPSY INSTRUMENTKNWSubstantially Equivalent
K924671BAXTER ADULT/PEDI INFANT SINGLE/USE MAN RESUSCITBTMSubstantially Equivalent
K924610BAXTER ADULT/PEDI/INFANT SINGLE USE MAN RESUSCITBTMSubstantially Equivalent
K912203EMS SINGLE USE MANUAL RESUSCITATORSBTMSubstantially Equivalent
K913014EMS PERCUSSORBYISubstantially Equivalent
K874746SEALFLEX MASKBSJSubstantially Equivalent
K871851RIBBED CUSHION MASKBSJSubstantially Equivalent

Registered establishments

FDA registered establishments for Engineered Medical Systems, LLC, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30099733363009973336Engineered Medical Systems, LLC3325 Appling Rd, Bartlett, TN 38133 US2026and 89 more, listed in full below
18325621832562Intersurgical Inc.2055 Executive Dr, Indianapolis, IN 46241 US2026and 11 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
RecallProductReasonClassificationInitiatedStatus
Z-1058-2013Respironics SealFlex Single Port Ribbed Mask (Infant). For general use in respiratory and anesthesia applications as a conduit for various gases to resuscitate or to enhance breathing abilities of the patient. .The mask inside the package has been identified as "Neonatal" in size and not "Infant" as the labeling indicates.Class ITerminated

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.

What MDM checks, and what it does not

MDM coverage

MDM coverage of this company lists here, newest first. Submit news.

Is this your company?

This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.

Claiming lets Engineered Medical Systems, LLC edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.

Claim this page

Data as of , FDA export datePage updated Source: openFDA, public domain