Custom Medical Products, Ltd.

Mchenry, IL, US

Custom Medical Products, Ltd. appears in FDA device records in Mchenry, IL. FDA records list 14 510(k) clearances between 1983-12-27 and 2000-06-09, no PMA records and no registered establishments. As of 2026-09-10, FDA records show no recalls for this company.

510(k) clearances: 14
PMA records: 0
Recall records: 0
Registered establishments: 0

510(k) clearance history

FDA records hold 14 510(k) clearances for Custom Medical Products, Ltd. between 1983 and 2000. The busiest year on record is 1994, with 5. The most recent is 2000, with 1.

Clearances by year, as a table

510(k) clearance decisions for Custom Medical Products, Ltd., by decision year
Year	Clearances
1983	1
1988	1
1989	2
1990	2
1993	1
1994	5
1995	1
2000	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K994199	VARIOUS STERILE AND NON-STERILE SURGICAL DRAPES, (I.E., DISPOSABLES MINOR PROCEDURE DRAPES, LARGE APERTURE DRAPES, ABSOR	KKX	Substantially Equivalent	2000-06-09
K931417	STERILE EQUIPMENT COVERS	MMP	Substantially Equivalent	1995-07-06
K931456	SURGICAL DRAPE AND GOWN TRAY	FYA	Substantially Equivalent	1994-07-08
K931455	HEAD SHEET	KKX	Substantially Equivalent	1994-05-05
K931418	SURGICAL DRAPE	KKX	Substantially Equivalent	1994-05-05
K930815	ABDOMINAL / THORACIC PATIENT DRAPE	KKX	Substantially Equivalent	1994-05-05
K931844	CUSTOM PROCEDURE MEDICAL TRAY OR KIT	LRO	Unknown	1994-01-25
K926519	SURGICAL GOWN	FYA	Substantially Equivalent	1993-08-12
K900848	ENEMA KIT 'STRAIGHT' DESIGN	FCE	Substantially Equivalent	1990-04-13
K900847	ENEMA KIT 'Y' DESIGN	FCE	Substantially Equivalent	1990-04-13
K895084	APERTURE	IZS	Substantially Equivalent	1989-10-27
K893681	MAMM-AIRE CP	IZO	Substantially Equivalent	1989-07-20
K880905	MAMMOGRAPHY MOVING GRID BUCKY	IZH	Substantially Equivalent	1988-03-21
K834076	ARTHROSCOPIC LEG HOLDER 434-21	HRX	Substantially Equivalent	1983-12-27

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

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 Custom Medical Products, Ltd. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.

The self-serve claim needs an FDA establishment registration, FEI or owner-operator number on the company’s record, and we hold none for Custom Medical Products, Ltd.. The only route for a company with no identifier on record is a person here: write to us, and one looks at the record and sends the same claim link by hand.

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