Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
1976 — Predicate Candidate Screening
1,085 FDA 510(k) clearances under this clearance year; the 50 most recent screened below.
22 daysmedian FDA review time
77 days90th percentile
1,085clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K760917 | LAS-R HUMAN HAPTOGLOBIN TEST | Hyland Therapeutic Div., Travenol Laboratories | 1976-12-30 | 63 | 0 |
| K761295 | RESP. AIR TEMP. CONTROL & HAZARD MON. | Harris-Lake, Inc. | 1976-12-30 | 9 | 0 |
| K761069 | P.S.M. BOTIQUE CAP | The Owenby Co. | 1976-12-30 | 44 | 0 |
| K761299 | DISPOSABLE NEBULIZER | Mcgaw Respiratory Therapy | 1976-12-30 | 9 | 0 |
| K761270 | IMMUNO-TEC II OT AGAROSE PLATE KIT | Behring Diagnostics, Inc. | 1976-12-30 | 14 | 0 |
| K761303 | IMMU-SAL IMMUNOHEMATOLOGICAL SALINE | Dade, Baxter Travenol Diagnostics, Inc. | 1976-12-30 | 8 | 0 |
| K761241 | PRE-DUCED SURGI-SWAB & TRANSPORTER TUBE | Gibco Laboratories Life Technologies, Inc. | 1976-12-30 | 17 | 0 |
| K761064 | COVENTRY STAPLE | Depuy, Inc. | 1976-12-30 | 42 | 0 |
| K761330 | SYNTEX SYSTEM 6000 | Syntex Corp. | 1976-12-30 | 3 | 0 |
| K761068 | P.S.M. BOUFFANT CAP | The Owenby Co. | 1976-12-30 | 44 | 0 |
| K760954 | CROWNTEX EXAM. CAPE & GOWN | Graham Manufacturing Co. | 1976-12-30 | 58 | 0 |
| K761235 | LASER STANDARD SERUM | Behring Diagnostics, Inc. | 1976-12-30 | 20 | 0 |
| K761071 | P.S.M. JUSTA KAP | The Owenby Co. | 1976-12-30 | 44 | 0 |
| K761298 | PRE-FILLED DISPOSABLE NEBULIZER | Mcgaw Respiratory Therapy | 1976-12-30 | 9 | 0 |
| K760765 | WHOLE BLOOD PLATELET COUNTER -2510 | Clay Adams, Div. Becton Dickinson & Co. | 1976-12-30 | 87 | 0 |
| K760662 | STERIL.WRAP(#221901,2,3,4,5,6,7,8,9) | C.R. Bard, Inc. | 1976-12-30 | 104 | 0 |
| K760904 | CLEANING AND ISOLATION ROOM KIT | American Hospital Supply Corp. | 1976-12-30 | 65 | 0 |
| K761070 | P.S.M. SURGICAL HOOD | The Owenby Co. | 1976-12-30 | 44 | 0 |
| K761267 | ANGIOTENSIN I IMMUTOPE KIT | Squibb & Sons, Inc. | 1976-12-30 | 14 | 0 |
| K760934 | HOSPITALITY SERVER | Plastics/Packaging | 1976-12-30 | 59 | 0 |
| K760951 | DEVON COOL FACE | Devon Industries, Inc. | 1976-12-30 | 59 | 0 |
| K761332 | HI-SENSITIVITY MODE OPTION FOR S60-1A | Syntex Corp. | 1976-12-30 | 3 | 0 |
| K760699 | MULTI-TEST | Lincoln Laboratories, Inc. | 1976-12-30 | 99 | 0 |
| K761051 | BI-FLOW NEEDLE | Dws, Inc. | 1976-12-30 | 45 | 0 |
| K760880 | ADDITIVE CAP (2B8905) | Travenol Laboratories, S.A. | 1976-12-30 | 70 | 0 |
| K761300 | NEBULIZER CONTROL UNIT | Mcgaw Respiratory Therapy | 1976-12-30 | 9 | 0 |
| K761282 | DATA-TOPE T4 RIA PROCEDURE | Dade, Baxter Travenol Diagnostics, Inc. | 1976-12-30 | 10 | 0 |
| K761305 | CENTRIA T3 RIA | Union Carbide Corp. | 1976-12-30 | 8 | 0 |
| K761311 | ACCRAASSAY RID KITS | Miles Laboratories, Inc. | 1976-12-30 | 7 | 0 |
| K761309 | OB-GYN CONTROL SERA (CODE 196300) | Amersham Corp. | 1976-12-30 | 7 | 0 |
| K761050 | HEPARIN PUMP | Dws, Inc. | 1976-12-30 | 45 | 0 |
| K761236 | ANTISERUM HUMAN (PRO.) NEPHELOMETRIC GR. | Behring Diagnostics, Inc. | 1976-12-30 | 20 | 0 |
| K760909 | THERMOMETER JARS AND CAPS | Plastics/Packaging | 1976-12-30 | 65 | 0 |
| K760921 | AIR PURIFIER | Vitaire Corp. | 1976-12-29 | 62 | 0 |
| K761262 | TRIGLYCERIDES (LIPASE) REAGENT SET | Worthington Biochemical Corp. | 1976-12-29 | 13 | 0 |
| K761238 | AUTO-INORGANIC PHOSPHORUS REAGENT | Harleco | 1976-12-29 | 16 | 0 |
| K761285 | PET-SCOPE | Diagnostic Information, Inc. | 1976-12-29 | 9 | 0 |
| K760898 | GOLDFARB LIVER CLAMP | Edward Weck, Inc. | 1976-12-29 | 64 | 0 |
| K761263 | CHOLESTEROL AUTOMATED REAGENT | Worthington Biochemical Corp. | 1976-12-29 | 13 | 0 |
| K760749 | SYSTEM 5 - SEMI-AUTOMATED CLIN. ANALY | Gilford Instrument Laboratories, Inc. | 1976-12-29 | 90 | 0 |
| K761239 | AUTO-INORGANIC PHOSPHORUS REAGENT | Harleco | 1976-12-29 | 16 | 0 |
| K761240 | AUTO-ENZYMATIC GLUCOSE | Harleco | 1976-12-29 | 16 | 0 |
| K761269 | GEMENI GPT (ALT) ASSAY | Electro-Nucleonics Laboratories, Inc. | 1976-12-29 | 13 | 0 |
| K761037 | INTERSORB LAPAROTOMY SPONGE | Chesebrough-Pond'S U.S.A. Co. | 1976-12-29 | 44 | 0 |
| K761261 | ENZYMATIC BUN (RATE) REAGENT KIT | Beckman Instruments, Inc. | 1976-12-29 | 13 | 0 |
| K761075 | SPORTS RECORDER (SR-10) | Eldeco | 1976-12-28 | 39 | 0 |
| K760675 | ELECTROSURGICAL DISPERSIVE PLATE | Aspen Laboratories, Inc. | 1976-12-28 | 102 | 0 |
| K761073 | POCKET TRANSMITTER (PT-10) | Eldeco | 1976-12-28 | 39 | 0 |
| K761077 | TREND ANALYZER | Eldeco | 1976-12-28 | 39 | 0 |
| K761288 | P-1 ULTRASONIC ARTERIOGRAPH | D. Eugene Hokanson | 1976-12-28 | 8 | 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