Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
1977 — Predicate Candidate Screening
2,114 FDA 510(k) clearances under this clearance year; the 50 most recent screened below.
23 daysmedian FDA review time
77 days90th percentile
2,000clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K772188 | FSH RIA KIT (125I) | Diagnostic Products Corp. | 1977-12-22 | 27 | 0 |
| K771894 | LDH ISOENZYME CONTROL | Bio-Reagents & Diagnostics, Inc. | 1977-12-22 | 77 | 0 |
| K772184 | X-RAY SYSTEM FOR DENTAL APPLICATION | General Electric Co. | 1977-12-22 | 27 | 0 |
| K772257 | ALKALINE PHOSPHATASE TEST SET | Stanbio Laboratory | 1977-12-22 | 17 | 0 |
| K772251 | IMMUNOGLOBULIN A NEPHEL. ASSAY | Kallestad Laboratories, Inc. | 1977-12-22 | 13 | 0 |
| K772254 | IMMUNOGLOBULIN M NEPHEL. ASSAY | Kallestad Laboratories, Inc. | 1977-12-22 | 13 | 0 |
| K772211 | TEMP. ACRYLIC | Lactong Corp. | 1977-12-22 | 21 | 0 |
| K771854 | SPINSEP-T3 | Nuclear Diagnostics, Inc. | 1977-12-22 | 85 | 0 |
| K772170 | EMIT CENTRIFICHEM THYROXINE ASSAY | Syva Co. | 1977-12-22 | 31 | 0 |
| K772243 | TOXO TEST | Gull Laboratories, Inc. | 1977-12-22 | 14 | 0 |
| K772245 | HAPTOGLOBIN NEPHELOMETRIC ASSAY | Kallestad Laboratories, Inc. | 1977-12-22 | 13 | 0 |
| K772307 | PCO 2 ELECTROLYTE | Fisher Scientific Co., LLC | 1977-12-22 | 6 | 0 |
| K772215 | UNCONJUGATED ESTRIOL RIA KIT | Amersham Corp. | 1977-12-22 | 20 | 0 |
| K772222 | NEBULIZER SET-2C7105 | Travenol Laboratories, S.A. | 1977-12-22 | 17 | 0 |
| K771429 | DISP. TEFLON CONNHCTOR | Quinton, Inc. | 1977-12-22 | 143 | 0 |
| K772250 | ALPHA-1-ANTITRYPSIN NEPHEL. ASSAY | Kallestad Laboratories, Inc. | 1977-12-22 | 13 | 0 |
| K772249 | COMPLEMENT C3 NEPHELOMETRIC ASSAY | Kallestad Laboratories, Inc. | 1977-12-22 | 13 | 0 |
| K772306 | 125I DIGOXIN TEST SET | Wien Laboratories, Inc. | 1977-12-22 | 7 | 0 |
| K772248 | ALBUMIN NEPHELOMETRIC ASSAY | Kallestad Laboratories, Inc. | 1977-12-22 | 13 | 0 |
| K772246 | ALPHA-2-MACROGLOBULIN NEPHEL. ASSAY | Kallestad Laboratories, Inc. | 1977-12-22 | 13 | 0 |
| K772196 | RECEPTAL ATS TRAUMA KGA1900L | Sorensen Research | 1977-12-22 | 24 | 0 |
| K772252 | IMMUNOGLOBULIN G NEPHEL. ASSAY | Kallestad Laboratories, Inc. | 1977-12-22 | 13 | 0 |
| K772177 | TRI-TAB-RIA | Nuclear Medical Laboratories, Inc. | 1977-12-22 | 31 | 0 |
| K772253 | TRANSFERRIN NEPHELOMETRIC ASSAY | Kallestad Laboratories, Inc. | 1977-12-22 | 13 | 0 |
| K772247 | COMPLEMENT C4 NEPHELOMETRIC ASSAY | Kallestad Laboratories, Inc. | 1977-12-22 | 13 | 0 |
| K772289 | SCANNER, CT, 0400 | Pfizer Medical Systems, Inc. | 1977-12-21 | 9 | 0 |
| K772291 | DIAG. CONSOLE, INDEPENDENT | Pfizer, Inc. | 1977-12-21 | 9 | 0 |
| K772299 | TRANSPARENT MANIFOLD | Uni-Research | 1977-12-21 | 8 | 0 |
| K772233 | THERMOMETER RECAL ADAPTER | Info-Chem | 1977-12-20 | 13 | 0 |
| K772098 | DIGOXIN REAG. KIT FOR USE W/ARIA-II SYS | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1977-12-20 | 43 | 0 |
| K772301 | LAPAROSCOPY DRAPE, BOUNDARY | Procter & Gamble Mfg. Co. | 1977-12-20 | 6 | 0 |
| K772268 | DEMI-WALKER (REGULAR) | Med Fusion Systems, Inc. | 1977-12-20 | 11 | 0 |
| K771909 | DUAL WAVELENGTH PHOTOMETER, 1177 | Abbott Laboratories | 1977-12-20 | 70 | 0 |
| K772267 | QUADRAPLEGIC WALKING AID | Med Fusion Systems, Inc. | 1977-12-20 | 11 | 0 |
| K772227 | CATH KIT, SUPERPUBIC | American Hospital Supply Corp. | 1977-12-20 | 14 | 0 |
| K772183 | THYROID BINDING GLOBULIN | Corning Medical & Scientific | 1977-12-20 | 25 | 0 |
| K772286 | FORCEPS, SUTURE, AUTO | Hartmann Group, Inc. | 1977-12-20 | 8 | 0 |
| K772209 | CULTURE COLLEC. TRANS. SYS., DOUBLE DRY | Precision Dynamics Corp. | 1977-12-20 | 19 | 0 |
| K772181 | PROPHYLACTIC | Om Industries, Inc. | 1977-12-20 | 25 | 0 |
| K772120 | TOTAL HIP, CHARNELY TYPE | Depuy, Inc. | 1977-12-20 | 41 | 0 |
| K772176 | CYSTIC FIBROSIS TESTING INSTRUMENT | Laboratory Equipment Design Co. | 1977-12-20 | 29 | 0 |
| K772201 | HEARING AID, BODY TYPE, MODEL H | Maico Hearing Instruments, Inc. | 1977-12-20 | 20 | 0 |
| K772292 | T-TUBE WHELAN-MOSS | Davol, Inc. | 1977-12-20 | 8 | 0 |
| K771043 | SWAN GANZ | Clincal Instruments Corp. | 1977-12-20 | 194 | 0 |
| K771426 | PEDIATRIC INFUSION T | Quinton, Inc. | 1977-12-20 | 141 | 0 |
| K772066 | PULLEN PLASTIC-PORE PLUGS | Richard'S Medical Equip., Inc. | 1977-12-20 | 49 | 0 |
| K772060 | PROTECT IV GARD | Omnicon Medical Corp. | 1977-12-20 | 50 | 0 |
| K772242 | LAPAROSCOPY CONSOLE MODEL VIII | Kli | 1977-12-20 | 12 | 0 |
| K772179 | EMIT ANTIEPILEPTIC DRUG ASSAYS | Syva Co. | 1977-12-20 | 27 | 0 |
| K772136 | PERITONEAL CYCLER & MANIFOLD SET | Physio-Control Corp. | 1977-12-20 | 36 | 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