Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
E. R. Squibb & Sons, Inc. — Predicate Candidate Screening
32 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
26 daysmedian FDA review time
48 days90th percentile
32clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K821494 | RIA STAT 16 | E. R. Squibb & Sons, Inc. | 1982-06-03 | 16 | 0 |
| K820616 | ANGIOTENSIS I-SQUIBB RADIOIMMUNOASSAY | E. R. Squibb & Sons, Inc. | 1982-03-26 | 18 | 0 |
| K820340 | T3 UPTAKE-SQUIBB DIAGNOSTIC KIT | E. R. Squibb & Sons, Inc. | 1982-03-04 | 24 | 0 |
| K820341 | CORTISOL-SQUIBB RADIOIMMUNOASSAY KIT | E. R. Squibb & Sons, Inc. | 1982-03-04 | 24 | 0 |
| K811240 | SUR-FIT LOOP OSTOMY O.R. SET | E. R. Squibb & Sons, Inc. | 1981-06-16 | 43 | 0 |
| K811239 | SUR-FIT DISPOSABLE CONVEX INSERT | E. R. Squibb & Sons, Inc. | 1981-06-09 | 36 | 0 |
| K811160 | SUR-FIT IRRIGATION SLEEVE | E. R. Squibb & Sons, Inc. | 1981-06-02 | 35 | 0 |
| K811163 | SUR-FIT DISPOSABLE FANGE CAP | E. R. Squibb & Sons, Inc. | 1981-05-21 | 23 | 0 |
| K810966 | DIAGOXIN SQUIBB RADIOIMMUNOASSAY KIT | E. R. Squibb & Sons, Inc. | 1981-04-21 | 13 | 0 |
| K810211 | T3 RIA KIT | E. R. Squibb & Sons, Inc. | 1981-02-10 | 15 | 0 |
| K803100 | STOMAHESIVE PASTE PROTECTIVE SKIN BARR | E. R. Squibb & Sons, Inc. | 1981-01-08 | 30 | 0 |
| K802883 | T3-SQUIBB RIA KIT | E. R. Squibb & Sons, Inc. | 1980-12-19 | 32 | 0 |
| K802455 | ESTRIOL-SQUIBB RIA KIT | E. R. Squibb & Sons, Inc. | 1980-10-31 | 23 | 0 |
| K802456 | T4-SQUIBB RIA KIT | E. R. Squibb & Sons, Inc. | 1980-10-31 | 23 | 0 |
| K802173 | URIHESIVE STRIPS | E. R. Squibb & Sons, Inc. | 1980-09-26 | 17 | 0 |
| K802172 | URIHESIVE SYSTEM | E. R. Squibb & Sons, Inc. | 1980-09-26 | 17 | 0 |
| K801703 | SUR-FIT SYSTEM STERILE O.R. SETS | E. R. Squibb & Sons, Inc. | 1980-09-09 | 47 | 0 |
| K801702 | SUR-FIT SYSTEM PRE-OPERATION SET | E. R. Squibb & Sons, Inc. | 1980-08-27 | 34 | 0 |
| K800997 | DIGOXIN CLASP RIA KIT | E. R. Squibb & Sons, Inc. | 1980-05-08 | 13 | 0 |
| K800495 | SUR-FIT UROSTOMY POUCH & URINARY BAG | E. R. Squibb & Sons, Inc. | 1980-04-08 | 35 | 0 |
| K792382 | STOMAHESIVE POWDER | E. R. Squibb & Sons, Inc. | 1979-12-20 | 24 | 0 |
| K790477 | TY RIA KIT, AUTOMATED ASSAY SYSTEM | E. R. Squibb & Sons, Inc. | 1979-04-26 | 48 | 0 |
| K790417 | T3 UPTAKE KIT | E. R. Squibb & Sons, Inc. | 1979-04-20 | 51 | 0 |
| K790268 | CORTISOL RIA KIT | E. R. Squibb & Sons, Inc. | 1979-04-04 | 58 | 0 |
| K781660 | RIA, DIGOXIN | E. R. Squibb & Sons, Inc. | 1978-10-24 | 26 | 0 |
| K781659 | ASSAY SYSTEM, GAMMAFLO, AUTOMATED | E. R. Squibb & Sons, Inc. | 1978-10-24 | 26 | 0 |
| K781088 | OSTOMY APPLIANCE BELT | E. R. Squibb & Sons, Inc. | 1978-08-18 | 50 | 0 |
| K780511 | SNAP-FIT | E. R. Squibb & Sons, Inc. | 1978-04-21 | 22 | 0 |
| K780454 | ACTIVE-LIFE | E. R. Squibb & Sons, Inc. | 1978-04-21 | 32 | 0 |
| K771142 | T3 CLASP RIA KIT | E. R. Squibb & Sons, Inc. | 1977-07-14 | 17 | 0 |
| K770915 | CLASP RIA KIT, HTSH | E. R. Squibb & Sons, Inc. | 1977-06-14 | 26 | 0 |
| K770069 | DIGOXIN CLASP TM RIA KIT | E. R. Squibb & Sons, Inc. | 1977-01-18 | 5 | 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