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

1979 — Predicate Candidate Screening

2,434 FDA 510(k) clearances under this clearance year; the 50 most recent screened below.

34 daysmedian FDA review time

84 days90th percentile

2,000clearances measured

K-number	Device	Applicant	Decided	Review days
K792486	SERACON-SRI (PROD. # D029	Bhp Diagnostix, Inc.	1979-12-31	28
K792449	CENTRIA FERRITIN RIA	Union Carbide Corp.	1979-12-31	31
K792476	HELENA FACTOR XI DEFICIENT SUBSTRATE	Helena Laboratories	1979-12-31	28
K792467	PLATELET-CHEX FOR BLOOD CENTERS	Streck Laboratories, Inc.	1979-12-31	28
K792360	HANSAPOR STERILE	Beiersdorf, Inc.	1979-12-31	40
K792421	DECARBOXYLASE BROTH BASE WITH OR WITH-	Isle Media and Sterile Products, Inc.	1979-12-31	34
K792420	SIM MEDIUM	Isle Media and Sterile Products, Inc.	1979-12-31	34
K792593	PHENYLETHANOL AGAR	Isle Media and Sterile Products, Inc.	1979-12-31	14
K792230	AVL MODEL 940 AUTOMATIC PH/BLOOD GAS	Gauntlet Technology Corp.	1979-12-31	56
K792586	HALO SUPPORT JACKET & ASSOC. HARDWARE	Depuy, Inc.	1979-12-31	14
K792596	TRYPTIC SOY AGAR W/PHENYLETHANOL &	Isle Media and Sterile Products, Inc.	1979-12-31	14
K791458	AGGLUTINOTEST-THYROGLOBULIN	Volu Sol Medical Industries	1979-12-31	147
K791455	AGGLUTINOTEST-INFECTIOUS MONONUCLEOSIS	Volu Sol Medical Industries	1979-12-31	147
K792604	LIFELINE TLE ENDOCARDIAL PACING LEAD,	Intermedics, Inc.	1979-12-31	13
K792594	TRYPTIC SOY AGAR W/LECITHIN & POLYSRBTE.	Isle Media and Sterile Products, Inc.	1979-12-31	14
K792422	TETRATHIONATE BROTH BASE	Isle Media and Sterile Products, Inc.	1979-12-31	34
K792507	HELENA FACTOR V DEFICIENT SUBSTRATE	Helena Laboratories	1979-12-31	27
K792639	H-H SHUNT INTRODUCER	Holter-Hausner Intl.	1979-12-31	11
K792358	SANDARE CYANMETHEMOGLOBIN STANDARD	Sandare Chemical Co., Inc.	1979-12-31	40
K792485	SERACON-SRI	Bhp Diagnostix, Inc.	1979-12-31	28
K792584	ACA ETHOSURIMIDE TEST PACK	E.I. Dupont DE Nemours & Co., Inc.	1979-12-31	17
K792595	SF MEDIUM (SF BROTH, STREPTOCOCCUS	Isle Media and Sterile Products, Inc.	1979-12-31	14
K792573	ALARM USED W/MONITORING SPIROMETER	Empire Plastics Manufacturer	1979-12-31	18
K791461	AGGLUTINOTEST-C-REACTIVE PROTEIN	Volu Sol Medical Industries	1979-12-31	147
K792503	SANDARE CYANMETHEMOGLOBIN REAGENT	Sandare Chemical Co., Inc.	1979-12-31	27
K792511	HELENA FACTOR VII DEFICIENT SUB. PLASMA	Helena Laboratories	1979-12-31	26
K792475	HELENA FACTOR IX DEFICIENT SUBSTRATE	Helena Laboratories	1979-12-31	28
K792570	PATIENT TROLLEY B49	Ets Rene Marzet	1979-12-31	18
K792601	LIFELIFT MODELS ONE AND TWO	Corda Int'L Holiday, Inc.	1979-12-31	13
K792496	VOLU-SOL NMB RETICULOCYTE STAIN	Volu Sol Medical Industries	1979-12-31	27
K792487	SERACON-SRII	Bhp Diagnostix, Inc.	1979-12-31	28
K792542	VOGEL-JOHNSON AGAR	Isle Media and Sterile Products, Inc.	1979-12-31	21
K792508	HELENA FACTOR X DEFICIENT SUBSTRATE	Helena Laboratories	1979-12-31	27
K791507	AGGLUTINOTEST-RHEUMATOID ARTHRITIS	Volu Sol Medical Industries	1979-12-31	152
K792481	CULTURE PLATES & TUBED MEDIA	Laboratory Products, Inc.	1979-12-31	42
K792185	PIASMA SAFE	Cry-O-Safe, Inc.	1979-12-28	58
K791977	PSORALITE MARK I	Paul B. Elder Co.	1979-12-28	87
K792425	DECARBOXYLASE MOELLER BASE WITH OR WITH-	Isle Media and Sterile Products, Inc.	1979-12-27	30
K792479	CHEM-STRATE AMYLASE	General Diagnostics	1979-12-27	24
K792530	PLAQUE-X DENTURE CLEANER	Nexell Corp.	1979-12-27	20
K792544	LYSINE IRON AGAR	Isle Media and Sterile Products, Inc.	1979-12-27	17
K792506	RIONET HEARING AID HB-68L	Rion Acoustic Instruments, Inc.	1979-12-27	23
K792078	MODEL 449 ELECTROCARDIOCORDER	Del Mar Avionics	1979-12-27	73
K792505	RIONET HEARING AID HB-32T	Rion Acoustic Instruments, Inc.	1979-12-27	23
K792353	INTRA-ARTICULATED EDGER-PLANER SYSTEM	Richard Wolf Medical Instruments Corp.	1979-12-27	37
K792575	BACTEC BACTERIAL DETECTION SYSTEM	Bd Becton Dickinson Vacutainer Systems Preanalytic	1979-12-27	14
K792272	DEXIDE DIS. SUR. SCRUB SPONGE W/PARACHLO	Dexide, Inc.	1979-12-27	44
K792468	FEEDING TUBE PLACEMENT STYLET	Biosearch Medical Products, Inc.	1979-12-27	24
K792484	TIPSEP-T3U TRIIODOTHYRONINE UPTAKE	Nuclear Diagnostics, Inc.	1979-12-27	24
K792361	SYSTEM 103 CHEMISTRY ANALYZER	Gilford Instrument Laboratories, Inc.	1979-12-27	36

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