Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

1988 — Predicate Candidate Screening

4,299 FDA 510(k) clearances under this clearance year; the 50 most recent screened below.

64 daysmedian FDA review time

169 days90th percentile

2,000clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K884669	EXEL 2002 & 2002FS CT SCANNER	Elscint, Inc.	1988-12-30	52	0
K884551	DADE FACTOR IX CHROMOGENIC ASSAY	Baxter Healthcare Corp	1988-12-30	60	0
K881648	TRANSFER CONTAINER HUMIDIFIER	Newport Biosystems, Inc.	1988-12-30	259	0
K884544	DADE FACTOR VIII CHROMOGENIC ASSAY	Baxter Healthcare Corp	1988-12-30	60	1
K882830	INFUSION PUMP	Pemlab Corp.	1988-12-30	175	0
K884667	EXEL 905 SERIES CT SCANNER	Elscint, Inc.	1988-12-30	52	0
K885076	COAG-A-MATE XC/XC PLUS VERSION D.00 SOFTWARE	Organon Teknika Corp.	1988-12-30	22	0
K884668	EXEL 1002 CT SCANNER	Elscint, Inc.	1988-12-30	52	0
K885163	DIOPTICS EYESHIELDS	Dioptics	1988-12-30	17	0
K884537	AE-800PA EEG MODULE	Nihon Kohden America, Inc.	1988-12-29	62	0
K885044	BEHRING POLAROID OPUS THEOPHYLLINE	Pb Diagnostic Systems, Inc.	1988-12-29	24	0
K884888	MODIFIED NEW JERSEY ACETABULAR COMP. & BONE SCREWS	Protek, Inc.	1988-12-29	37	0
K884242	MODIFIED CHICK AMBULATORY HALO	Chick Medical Products	1988-12-29	79	0
K884784	VIRGO(R) MICROWELL ALT ASSAY	Electro-Nucleonics, Inc.	1988-12-29	44	0
K884993	VISUAL BLOOD GLUCOSE TEST SYSTEM	Diagnostic Systems	1988-12-29	28	0
K883340	NEURAL MAGNETIC STIMULATOR, THE D190	Tracor Northern, Inc.	1988-12-29	142	0
K884263	ROGOZINSKI SPINAL SYSTEM	Richards Medical Co., Inc.	1988-12-29	79	0
K884414	CLENSATRON AUTOMATIC CONTACT LENS CLEANER	Questech Intl., Inc.	1988-12-29	70	0
K884035	SAITRON 430 RANDOM ACCESS CHEMISTRY ANALYZER	Sclavo, Inc.	1988-12-29	97	0
K884385	FIBRI-PREST/THROMBIN-PREST CONTROLS	American Bioproducts Co.	1988-12-28	71	0
K883315	EDENTRACE MULTI-CHARTER MODEL 3700	Edentec Corp.	1988-12-28	145	0
K884384	THROMBIN-PREST REAGENT KIT	American Bioproducts Co.	1988-12-28	71	0
K884955	CARDIOCAP(TM) CM-104 MONITOR	Datex Division Instrumentarium Corp.	1988-12-28	29	0
K883618	PERFECTA II TOTAL HIP SYSTEM	Orthomet, Inc.	1988-12-28	126	0
K884251	ALLERGAN LENS CASE	Allergan Optical	1988-12-28	78	0
K885093	COULTER STKS	Coulter Electronics, Inc.	1988-12-28	19	0
K882717	PROCEDURE PACKS CONTRAST MEDIA SETS	Procedure Packs, Inc.	1988-12-28	180	0
K884485	KD ACTIVATED PARTIAL THROMBOPLASTIN TIME REAGENT	King Diagnostics, Inc.	1988-12-28	64	0
K884891	OC-100 OXIMETER INTERFACE CALIBRATOR	Telediagnostic Systems, Inc.	1988-12-28	36	0
K884153	CANDELA MINIFLEX DEFLECTABLE URETEROSCOPE	Candela Laser Corp.	1988-12-28	89	0
K884351	UNIREST PL, ANTE./POST. RESTORATIVE, PASTE/LIQUID	Scientific Pharmaceuticals, Inc.	1988-12-28	75	0
K885132	FACSMATE SAMPLE HANDLING DEVICE	Bd Becton Dickinson Vacutainer Systems Preanalytic	1988-12-28	16	0
K885121	CELL SCRAPER	Bd Becton Dickinson Vacutainer Systems Preanalytic	1988-12-28	16	0
K883617	LIFEPAK 50 MONITOR/DEFIBRILLATOR	Physio-Control Corp.	1988-12-28	126	0
K884908	ULTRAFLOTATION MEDICAL WHEELCHAIR	Medical Flotation Systems, Inc.	1988-12-27	34	0
K883790	SURGICAL CLAMP INSERTS	Applied Vascular Devices, Inc.	1988-12-27	111	3
K884320	PROPAQ 106(TM)	Protocol Systems, Inc.	1988-12-27	75	0
K883934	CELL SAVER HAEMOLITE B AUTO. BLOOD RECOVERY SYSTEM	Haemonetics Corp.	1988-12-27	103	0
K882935	NEBULIZER HEATER	Automatic Liquid Packaging, Inc.	1988-12-27	167	0
K884347	MODIFIED DISPOSABLE COAXIAL BIPOLAR PEN	Advanced Surgical Products, Inc.	1988-12-27	74	0
K885105	SLIDING ARM SUPPORT	Rolcontrol Products, Co., Inc.	1988-12-27	15	0
K884683	FERRITIN SEROZYME IMMUNOENZYMETRIC ASSAY	Serono-Baker Diagnostics, Inc.	1988-12-27	49	0
K885062	MODIFIED Q-SERIES OF TREADMILLS	Quinton, Inc.	1988-12-27	21	0
K884956	CARDIOCAP(TM) CTO-104 MONITOR	Datex Division Instrumentarium Corp.	1988-12-27	28	0
K884862	ANCHOR DOUBLE-EDGE MYRINGOTOMY BLADE	Anchor Products Co.	1988-12-27	36	0
K884812	KARMA-RS, KARMA-FS WHEELCHAIRS	Orthofab, Inc.	1988-12-27	40	0
K885104	LAYDOWN ARM SUPPORT MECHANISM	Rolcontrol Products, Co., Inc.	1988-12-27	15	0
K884821	ABBOTT SPECTRUM(R) BICARBONATE REAGENT	Abbott Laboratories	1988-12-27	40	0
K883909	SURGICAL SPRING CLIPS	Applied Vascular Devices, Inc.	1988-12-27	103	0
K884397	PHARMASEAL STERILE WOUND CARE DRESSING	Baxter Healthcare Corp	1988-12-27	69	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