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

INX — Predicate Candidate Screening

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

77 daysmedian FDA review time

279 days90th percentile

28clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K972176	HOME CARE BEAD BED	Kinetic Concepts, Inc.	1998-01-16	221	0
K964223	CLINITRON RITE-HITE	Hill-Rom, Inc.	1997-05-28	217	2
K943385	CLINITRON ELEXIS	Ssi Medical Services, Inc.	1995-02-27	229	0
K942184	CLINITRON AT HOME AIR FLUIDED THERAPY	Ssi Medical Services, Inc.	1995-02-07	279	2
K931168	X-20 AIR SUPPORT BED	American Life Support Technology, Inc.	1994-02-17	346	0
K934689	LOW AIR LOSS MATTRESS, MODIFICATION	Cardio Systems, Inc.	1994-02-02	163	0
K924973	DYLNAMEDICS A.S.A.P.	Dynamedics, Inc.	1993-10-15	380	0
K926402	COMFORT CARE LOW AIR LOSS THERAPY BED	Ch Administration, Inc.	1993-03-24	93	0
K924686	REM-AIR	Mellenair Ent., Inc.	1993-02-12	149	0
K920112	CLINITRON C-II	Support Systems Intl.	1992-01-24	14	2
K913654	SMITH AND DAVIS PRESSURE THERAPY SYSTEM	Smith & Davis Mfg. Co.	1991-11-22	98	0
K911246	THE MEDISCUS PEDCARE MANAGEMENT SYSTEM-MODEL 2	The Medical Group, Inc.	1991-06-06	77	0
K911057	DERMATEK 4000	Anacom General Corp.	1991-04-05	28	0
K904008	STAGE IV, AIR-FLUIDIZE BED	Unique Flotation Systems, Inc.	1990-10-10	42	0
K890523	SUPERCAIR	Ssi Medical Services, Inc.	1989-02-10	8	0
K884835	TASSI MK2	Therapy Air Support Systems, Inc.	1988-12-07	19	0
K884529	MICROAIR FLUIDIZED AIR BED	Gsi Development Co.	1988-11-18	21	0
K881917	FLUIDAIR	Kinetic Concepts, Inc.	1988-11-14	189	0
K881705	MODEL 5000 AIR-FLUIDIZED SUPPORT SYSTEM	Surgi-Med, Inc.	1988-07-13	85	0
K880340	MODIFIED AIR FLUIDIZED BED, KINAIR	Kinetic Concepts, Inc.	1988-02-16	21	0
K870045	SKYTRON MODEL 610-2	Skytron, Div. the Kmw Group, Inc.	1987-02-04	30	0
K852036	AIR PLUS AIR FLUIDIZED THERAPY SYSTEMS	Air Plus, Inc.	1985-09-05	119	0
K843389	CLINITRON AIR FLUIDIZED SUPPORT J-101UD	Uhi Corp.	1984-09-05	7	0
K842987	APOLLO AIR FLUIDIZED BED	Apollo Fluid Dynamics	1984-08-02	3	0
K834344	MED-OPEDIC SLEEP SYSTEM	Bemco Mattress Co.	1984-01-17	36	0
K813584	CLINITRON AIR FLUIDIZED SUPPORT SYSTEM	Uhi Corp.	1982-01-12	15	2
K810543	NEO-WAVE SYSTEM	Gaymar Industries, Inc.	1981-03-06	7	0
K760712	MEDISCUS AIR BED	Hsi Products, Inc.	1976-11-24	61	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