Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

KNC — Predicate Candidate Screening

26 FDA 510(k) clearances under this product code; the 50 most recent screened below.

56 daysmedian FDA review time

428 days90th percentile

26clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K001261	L720 EXAMINATION CHAIR	Luneau Gynecologie SA	2000-06-08	50	0
K932035	NON-LINTING DELIVERY BLANKET	Amsco Sterile Recoveries, Inc.	1994-05-26	394	0
K924420	MEDICAL DISPOSABLE BEDDING	Hill-Rom, Inc.	1993-12-10	465	0
K914544	BD6000 THE OPTIMA & BD5000 BIRTHING BED	Lic Care, Inc.	1993-11-24	776	0
K915779	AFFINITY BED MODEL 3600 SERIES	Hill-Rom, Inc.	1993-02-24	428	10
K903973	GARDOSI BIRTHING CUSHION	Graphic Controls Corp.	1990-09-27	30	0
K884868	OBSTETRICAL SAFETY SYSTEM	Buckman Co., Inc.	1989-03-01	100	0
K870745	STRYKER MODEL 977 BIRTHING BED	Stryker Corp.	1987-02-27	2	0
K864194	PALMER OBSTETRIC BRACE	Ad-Tech Medical Instrument Corp	1987-01-14	79	0
K862931	MERIVAARA OBSTETRIC CHAIR/BED-MODEL 358	Global Medical Prods, Inc.	1986-08-07	3	0
K861030	LABOR-DELIVERY STRETCH/BED	Adel Medical , Ltd.	1986-04-23	36	0
K852174	MERIVAARA OBSTETRIC CHAIR/BED MODEL 358	Daun International, Inc.	1985-09-06	109	0
K852171	CAT. NO. S-5300-E BIRTHING BED	Shampaine/Wilson	1985-08-30	102	0
K844183	PALMER OBSTETIC BRACE	Mic Medical Corp.	1985-02-04	101	0
K842962	LORRAINE DSL LABOR & DELIVERY BED	Pulley-Kellam Co., Inc.	1984-09-25	60	0
K833321	LABOR/DELIVERY/RECOVERY BED LDR-600	Adel Medical , Ltd.	1983-11-14	49	0
K831998	BIRTHWELL BIRTHING SYSTEM	Qulab Co.	1983-09-12	83	0
K831309	DELIVERY 4 TABLE	Amsco Co.	1983-06-15	54	0
K830873	S & W MODEL ASO	S & W Enterprises, Inc.	1983-05-13	56	0
K820175	O.N.A.T.	Latex Medical Devices, Inc.	1982-01-29	8	0
K811902	CENTURY BIRTHING CHAIR	Century Manufacturing Co.	1981-08-25	55	0
K812141	LIC OBSTETRICAL TABLE	Lada Intl., Inc.	1981-08-25	28	0
K801622	ADEL MEDICAL BIRTHING BED, MOD. LD-400	Adel Medical , Ltd.	1980-08-14	30	0
K792568	OBSTETRICAL BEDS	Ets Rene Marzet	1980-01-28	46	0
K790950	S/A 7800 BIRTH SUPPORT CHAIR	Schlosser Alberti Co.	1979-08-03	74	0
K770437	TABLE, EXAMINATION	I E Industries	1977-03-23	16	0

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda