Carapace, Inc.

Mchenry, IL, US

Carapace, Inc. appears in FDA device records in Mchenry, IL. FDA records list 22 510(k) clearances between 1979-02-16 and 1994-03-23, no PMA records and no registered establishments. As of 2026-09-10, FDA records show no recalls for this company.

510(k) clearances: 22
PMA records: 0
Recall records: 0
Registered establishments: 0

510(k) clearance history

FDA records hold 22 510(k) clearances for Carapace, Inc. between 1979 and 1994. The busiest year on record is 1994, with 11. The most recent is 1994, with 11.

Clearances by year, as a table

510(k) clearance decisions for Carapace, Inc., by decision year
Year	Clearances
1979	2
1981	1
1984	1
1988	1
1993	6
1994	11

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K931722	CARAPACE LABOR AND DELIVERY SETS	MLS	Unknown	1994-03-23
K931822	CARAPACE PELVIC EXAM TRAYS	MLT	Unknown	1994-03-07
K931729	I.V. START KIT	FOZ	Unknown	1994-02-22
K931820	CARAPACE STILLWATER BOWL SET	LRO	Unknown	1994-02-07
K931669	CARAPACE DEBRIDEMENT KITS	FRG	Unknown	1994-02-07
K931760	CARAPACE PACKING GAUZE TRAYS	LRO	Unknown	1994-02-04
K932653	SWISSTEK 2000(TM) CAST REMOVAL SYSTEM	LGH	Substantially Equivalent	1994-01-28
K931819	CARAPACE SUTURE REMOVAL TRAYS	IRO	Unknown	1994-01-26
K931758	CARAPACE WOUND DRESSING KITS & LACERATION TRAYS	LRO	Unknown	1994-01-26
K931759	CARAPACE STERILE GAUZE TRAYS	LRO	Unknown	1994-01-25
K931670	CARAPACE EPIDURAL BLOCK & SPINAL MYELOGRAM TRAYS	CAZ	Substantially Equivalent	1994-01-25
K931673	CARAPACE CATARACT TRAYS	LRO	Unknown	1993-12-30
K931672	CARAPACE STERILE CAST PADDING	LGF	Substantially Equivalent	1993-12-15
K931824	CARAPACE INSTRUMLENT AND INSTRUMENT SETS	LRO	Unknown	1993-12-06
K931629	CARAPACE ANGIOGRAPHY TRAYS	DQO	Substantially Equivalent	1993-12-06
K931626	CARAPACE STERILE COTTON BALLS	FRL	Substantially Equivalent	1993-12-02
K931597	CARAPACE INCISION AND DRAINAGE TRAYS	MCZ	Unknown	1993-11-05
K883294	SYNTHETIC CAST TAPE	LGF	Substantially Equivalent	1988-08-30
K840976	VARIOUS DISPOSABLE KITS/TRAYS/INSTRU	FSM	Substantially Equivalent	1984-05-31
K813219	CARAFLEX ELASTIC POLYMER PLASTER BANDA	ITG	Substantially Equivalent	1981-12-17
K790970	SURGICAL FACE MASK	KKX	Substantially Equivalent	1979-07-03
K782107	LAP SPONGE	GDY	Substantially Equivalent	1979-02-16

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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