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

G.D. Searle and Co. · Predicate Candidate Screening

56 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

25 daysmedian FDA review time
74 days90th percentile
56clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K821159IN-LINE OXYGEN MONITORING SYSTEMG.D. Searle and Co.1982-05-25330
K811068BYPASS COILG.D. Searle and Co.1981-05-27400
K811071VENOUS OXYGEN PROBEG.D. Searle and Co.1981-05-05150
K803238INTRAVASCULAR CATHETERG.D. Searle and Co.1981-04-231210
K810630SILICONE ELASTOMER COATED LATEX FOLEYG.D. Searle and Co.1981-03-31220
K810131ADMINISTRATION SETG.D. Searle and Co.1981-02-26380
K802485SEARLE VASCULAR LOOPSG.D. Searle and Co.1981-02-121250
K801805METRONIDAZOLE DISCSG.D. Searle and Co.1981-02-101960
K810112SWR DISPOSABLE PREP RAZORG.D. Searle and Co.1981-02-04190
K802280WHITE KNIGHT DRAPE SEALG.D. Searle and Co.1980-10-10220
K802213WHITE KNIGHT BOVIE CORD/SUCTION TUBEG.D. Searle and Co.1980-10-10280
K801415LATEX FOLEY CATHETER (HYDROMER COATED)G.D. Searle and Co.1980-08-20650
K801414ERYTHROCATH INTRAVENOUS CATHETER PLA. U.G.D. Searle and Co.1980-08-13580
K800815ENTERAL & NASOGASTRIC SOL. ADMIN. SETG.D. Searle and Co.1980-07-211010
K800927WHITE KNIGHT DISP. STERILE BACK GOWNG.D. Searle and Co.1980-05-20290
K800929WHITE KNIGHT SURGICAL PACKG.D. Searle and Co.1980-05-20290
K800928WHITE KNIGHT SUPPLEMENTAL DRAPEG.D. Searle and Co.1980-05-20290
K800609CATHETER STYLETG.D. Searle and Co.1980-04-10240
K800611BOUGIE A BOULEG.D. Searle and Co.1980-04-08220
K800608STONE DISLODGERG.D. Searle and Co.1980-04-08220
K800610URETHRAL SOUNDG.D. Searle and Co.1980-04-08220
K800607SUPRAPUBIC TROCARG.D. Searle and Co.1980-04-08220
K800162ONCE TMG.D. Searle and Co.1980-02-11170
K800139SEARLE PHO/SONIC ALPHA 2000G.D. Searle and Co.1980-02-11210
K790285IMAGER, PHO/SONIC SERIES 2000G.D. Searle and Co.1979-03-08270
K781508WATERPATH SCANNING OPTIONG.D. Searle and Co.1978-09-26250
K781344OPTION PHO/SONIC B-MODE SCANNERG.D. Searle and Co.1978-08-21170
K780855GAMMA CAMERAG.D. Searle and Co.1978-06-02140
K772361LASER IMMUNONEPHELOMETRIC ANALYZERG.D. Searle and Co.1978-01-30340
K771976ECG AMPLIFIER/R WAVE TRIGGERG.D. Searle and Co.1977-11-09230
K772004HUMAN C4 COMPLEMENT CONTROL SERUMG.D. Searle and Co.1977-11-03130
K772003HUMAN REFERENCE SERUM C4 COMPLEMENTG.D. Searle and Co.1977-11-03130
K772002PLATES FOR HUMAN C4 COMPLEMENTG.D. Searle and Co.1977-11-02120
K771934LINEAR ARRAY B-MODE SCANNERG.D. Searle and Co.1977-10-25110
K771234TSH RIA REAGENT SETG.D. Searle and Co.1977-10-18990
K771768GOAT LAMBDA-LIGHT CHAIN ANTI-HUMAN SERUMG.D. Searle and Co.1977-10-07180
K771533DIGOXIN RIA KITG.D. Searle and Co.1977-08-25150
K771180GAMMA GOUNTING SYS., AUTO, MODEL 1400G.D. Searle and Co.1977-08-03340
K771239GOAT LAMBDA-LIGHT CHAIN ANTIHUMAN SERUMG.D. Searle and Co.1977-08-02220
K771238RID PLATES & INTENSI. FOR HUMAN IGE ETCG.D. Searle and Co.1977-07-1540
K770772PIPETTE, DISPENSING, MODEL ADP-30SDG.D. Searle and Co.1977-07-11740
K770773PIPETTE, DILUTING, MODEL ADP-30SDG.D. Searle and Co.1977-07-11740
K770765REAGENT SET, RENORPACEG.D. Searle and Co.1977-06-24580
K770739SERUM SET, THYROID CONTROLG.D. Searle and Co.1977-06-22620
K770737REAGENT SET, T-4, CPBG.D. Searle and Co.1977-06-22620
K770740RADIOASSAY TUBES & RADIOASSAY TUBE CAPSG.D. Searle and Co.1977-06-22620
K770738REAGENT, T-3 UPTAKEG.D. Searle and Co.1977-06-22620
K770677T-3 RIA REAGENT SETG.D. Searle and Co.1977-05-20390
K770676T-4 RIA REAGENT SETG.D. Searle and Co.1977-05-20390
K770220RADIONUCLIDE COMPUTED TOMOGRAPHY SYS.G.D. Searle and Co.1977-02-28250

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