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

LDQ — Predicate Candidate Screening

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

65 daysmedian FDA review time

254 days90th percentile

81clearances measured

K-number	Device	Applicant	Decided	Review days
K993797	EC-7701 FLUID WARMING CABINET	Enthermics Medical Systems, Inc.	2000-01-20	72
K992258	HOT SHOT FLUID WARMER IV FLUIDS	Infra-Med Technologies, Inc.	2000-01-12	190
K981032	PIV SYSTEM	Medical Solutions, Inc.	1998-09-02	167
K973747	CONTROLLED TEMPERATURE CABINET SYSTEM	Smith	1998-05-07	218
K955661	ACU-HALT	Glederer & Co., Inc.	1996-12-30	384
K955776	ACU-LAB	Glederer & Co., Inc.	1996-06-05	168
K945374	ACU-HALT	Eva-Health USA, Inc.	1995-08-09	280
K944961	PERSONAL ALARM SYSTEM (PAS)	Cytoprobe Corp.	1995-08-07	304
K942810	PALCO LABS COLD POUCH	Palco Laboratories, Inc.	1995-06-28	378
K930884	MEDICAL PROCEDURE TRAY, MODIFICATION	Enpak Medical Corp.	1995-03-21	762
K934703	MEDICOOL PROTECTALL	Avc Regulatory Compliance/Technical Services	1994-01-26	118
K925593	NORTEC STERILE WATER FOR DEVICE IRRIGATION	North American Sterilization & Packaging Co.	1993-12-03	393
K925588	NORTEC STER SALINE-O.9% SODIUM CHLOR FOR DEV IRRI	North American Sterilization & Packaging Co.	1993-12-03	393
K932714	ELECTRONIC GLOVE INTEGRITY MONITOR (EGIM)	Surface Mount Technology, Inc.	1993-12-01	180
K931153	ELPER(TM) BARRIER INTEGRITY MONITORING	Igea, S.R.L.	1993-11-18	254
K924837	DISP MONIT POUCH /GLOVE CK PAT EXAM GLOVE LEAK DET	Associated Ent., Inc.	1993-10-12	382
K930514	SURGIC-ALERT MONITOR	Novatec Medical Products, Inc.--Glove Monitor	1993-08-19	199
K915636	GLOVE CHECK PATIENT EXAMINATION GLOVE LEAK DETECT.	Associated Ent., Inc.	1992-07-13	209
K915662	BARRIER INTEGRITY MONITOR	Incomed, Inc.	1992-06-25	190
K913696	GLOVE-CHEK PORTABLE FLUID LEAKAGE SENSING DEVICE	Vertex Technical Group, Inc.	1992-02-18	183
K911955	OLYMPIC WARMETTE	Olympic Medical Corp.	1991-07-19	79
K902410	MEDICAL PROCEDURE TRAY	Sorex Medical	1990-11-20	173
K904598	ACCU PATH STERILE LABEL	Accu-Path	1990-10-30	20
K902682	STICK-GARD STERILE CAP	Integrated Medical Systems, Inc.	1990-09-26	99
K901237	GLOVE LEAK DETECTOR	Utah Medical Products, Inc.	1990-08-21	159
K901321	SHARP-SAFE, BIODEGRADEABLE,DISP., NEEDLE DISP. BOX	Sharp Safe, Inc.	1990-05-11	51
K901486	WEINSTEIN STYLE INSTRUMENT HOLDER	David Ayres Medical Co.	1990-05-02	34
K895674	MEDICOOL, CONTAINER FOR STORING INSULIN	Medicool, Inc.	1990-01-11	113
K894570	UNIVERSAL LIGHT CABLE	Expanded Optics, Inc.	1989-10-13	84
K891023	SIEMENS CEILING STAND 800F, 800 AND 810	Siemens Medical Electronics	1989-07-25	147
K892052	SARNS MEDICAL CART	3M Company	1989-06-15	78
K885055	INSU COOL	Dynex Trading Co.	1989-04-26	140
K884630	MULTI-PURPOSE HOLDER	Med-Dex Intl.	1988-11-22	15
K882388	MR. RAZOR II TWIN	Burney Products Corp.	1988-07-13	33
K880048	BLADE, SURGICAL PREP RAZOR STRAIGHT	Crescent Corp.	1988-03-04	58
K874186	BOWL, SPONGE, DISPOSABLE, STERILE & NON-STERILE	Busse Hospital Disposables, Inc.	1987-12-29	76
K864015	STERILABELS	Diversatronics, Inc.	1986-12-12	58
K863633	SAFETY PINS, ELASTIC BANDAGES & STOCKINETTES	Biological & Environmental Control Laboratories	1986-10-16	29
K854441	STUART GILMAN'S WEIGHT LOSS PLAN	Alpha Therapeutic Corp.	1986-02-10	97
K853185	CUDDLE CUSHION	The Cuddle Co.	1985-08-20	21
K851390	STERILE GENERAL HOSPITAL SUPPLIES	Biological & Environmental Control Laboratories	1985-05-29	50
K851276	ACTION PAC	South Mountain Medical	1985-05-15	44
K842016	DISPOS. POLY APRONS	Abco Dealers, Inc.	1984-07-03	46
K834062	STERILE LABELS	Devon Industries, Inc.	1984-02-04	71
K834063	STERILE RUBBER BANDS	Devon Industries, Inc.	1983-12-22	27
K832272	TOURNIQUET CUFF PRESSURE MONITOR #TCPM	Electromedics, Inc.	1983-11-28	139
K831799	PLASTIC DISPOSABLE RAZOR	I M, Inc.	1983-07-18	45
K822484	INFECTION CONTROL TOWEL	American Threshold Industries, Inc.	1982-09-30	44
K821396	OUT-RITE WASTE DISPOSABLE BAG	Kleen Test Products	1982-06-09	29
K813566	CARDIO-BAND	Cardio-Band, Inc.	1982-02-22	62

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