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

1980 — Predicate Candidate Screening

2,857 FDA 510(k) clearances under this clearance year; the 50 most recent screened below.

31 daysmedian FDA review time

73 days90th percentile

2,000clearances measured

K-number	Device	Applicant	Decided	Review days
K802932	MEASLES VIRUS & CONTROLS	Orion Diagnostica, Inc.	1980-12-31	42
K803011	DISPOSABLE DIAPHRAGM DONE	Sorensen Research	1980-12-31	33
K802933	MUMPS S & V ANTIGENS & CONTROLS	Orion Diagnostica, Inc.	1980-12-31	42
K802758	SELECTIVE CHARCOAL YEAST EXTRACT AGAR	Remel Co.	1980-12-31	57
K802939	HERPES SIMPLEX TYPE I	Orion Diagnostica, Inc.	1980-12-31	42
K803083	ORTHO HEMOTOLOGY CONTROL-NORMAL	Ortho Instruments	1980-12-31	26
K802936	RESPIRATORY SYNCYTIAL VIRUS ANTIGEN &	Orion Diagnostica, Inc.	1980-12-31	42
K802935	PARAINFLUENZA 1,2, & 3 ANTIGENS & CONTR	Orion Diagnostica, Inc.	1980-12-31	42
K803073	ORTHO HEMATOLOGY CONTROL	Ortho Instruments	1980-12-31	26
K802937	RUBELLA VIRUS ANTIGENS & CONTROLS	Orion Diagnostica, Inc.	1980-12-31	42
K803084	ORTHO HEMATOLOGY CONTROL ABNORMAL LOW	Ortho Instruments	1980-12-31	26
K802929	ADENO VIRUS & CONTROLS	Orion Diagnostica, Inc.	1980-12-31	42
K803177	MOIST HEAT PACK	Duro-Med Ind., Inc.	1980-12-31	15
K803105	SARNS INFANT ARTERIAL BUBBLE SENSOR	3M Health Care, Sarns	1980-12-31	22
K801970	UCLA SHOULDER	Howmedica Corp.	1980-12-31	134
K802934	MYCOPLASMA PNEUMONIAE ANTIGEN & CONTROL	Orion Diagnostica, Inc.	1980-12-31	42
K803064	ZIMMER ELECTRICAL MUSCLE STIMULATOR	Zimmer, Inc.	1980-12-31	27
K803165	ACETABULAR CEMENT COMPRESSOR	Zimmer, Inc.	1980-12-31	16
K802859	BEHIND-THE-EAR HEARING AID	Danavox, Inc.	1980-12-31	49
K802181	WISCONSIN BONE MINERAL ANALYZER	Lunar Radiation Corp.	1980-12-31	113
K802938	VARICELLA-ZOSTER ANTIGENS & CONTROLS	Orion Diagnostica, Inc.	1980-12-31	42
K802268	CRC(CYANMETHEMOGLOBIN REAGENT CONCENT	R&D Systems, Inc.	1980-12-31	106
K802180	WISCONSIN DUAL-PHOTON BONE ANALYZER	Lunar Radiation Corp.	1980-12-31	113
K802961	TRANSDUCER DOME, CAT.#SD-101	Sorensen Research	1980-12-31	40
K802750	NUVOX BEDSIDE TINNITUS MASKER	Hal-Hen Co., Inc.	1980-12-31	57
K803012	SHUR-PATCH TAPE PATCH	Shur Medical Corp.	1980-12-30	32
K802988	JOTA TUNGSTEN CARBIDE & STEEL DENT. BURS	Swiss American Metal Craft Corp.	1980-12-30	39
K802984	MEISINGER DIAMOND DENTAL BURS	Swiss American Metal Craft Corp.	1980-12-30	39
K803113	MENTOR 402 TRANSCUTANEOUS ELEC. STIMULAT	George H. Frisch	1980-12-30	20
K803119	LARGE WOUND DRESSING KIT	American Medical Disposable, Inc.	1980-12-30	20
K803016	HELENA HEMESPEC II TOTAL HEMOGLOBIN MET.	Helena Laboratories	1980-12-30	32
K802967	DISPERSALLOY-DISPERSED PHASE ALLOY SELF-	Johnson & Johnson Professionals, Inc.	1980-12-30	39
K802987	JOTA DIAMOND DENTAL BURS	Swiss American Metal Craft Corp.	1980-12-30	39
K803015	HEMESPEC II	Helena Laboratories	1980-12-30	32
K802658	RODEL ELECTRODERM PADS	Rodel Products Corp.	1980-12-30	67
K803121	MENTOR 150 TRANSCUTANEOUS NERVE STIMULA	George H. Frisch	1980-12-30	19
K802989	MEISINGER TUNGSTEN CARBIDE & STEEL DT.B.	Swiss American Metal Craft Corp.	1980-12-30	39
K803072	HIGH FREQUENCY AUDIOMETER DELMAR #20-K	Demlar Medical, Inc.	1980-12-30	25
K803174	CONPHAR PERCUSSION HAMMER(BUCK TYPE)	Conphar, Inc.	1980-12-30	15
K802991	ROLL STRETCH GAUZE	Abco Dealers, Inc.	1980-12-30	39
K803050	SPRAY, SYNTHETIC SMEAR	Laboratory Products, Inc.	1980-12-30	28
K803041	SERUM FREE TISSUE CULTURE MEDIA	Cartaya Assoc.	1980-12-30	29
K802983	THE INQUINAL RESORVOIR INSERTER	Lone Star Medical Products, Inc.	1980-12-30	39
K803038	PROXIMATE*II DISPOSABLE SKIN STAPLER	ETHICON, Inc.	1980-12-30	29
K802992	ELASTIC GAUZE	Abco Dealers, Inc.	1980-12-30	39
K803151	ECG & ULTRASOUND GELS, CREAMS & LOTION	Abco Dealers, Inc.	1980-12-30	18
K803117	CUSTOM DRESSING TRAY WET TO DRY	American Medical Disposable, Inc.	1980-12-23	13
K802946	MYCOLOGY CULTURE SYSTEM	Orion Diagnostica, Inc.	1980-12-22	33
K802644	EMERG. OXYGEN KIT #65350 & #65399 CASE	B & F Medical Products, Inc.	1980-12-22	59
K803036	PROFILE CARDIAC SET ASSAYED SERUM CONTR.	General Diagnostics	1980-12-22	21

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