Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FMH — Predicate Candidate Screening
23 FDA 510(k) clearances under this product code; the 50 most recent screened below.
36 daysmedian FDA review time
81 days90th percentile
23clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K900983 | TRI-TECH URINE SPECIMEN KIT | Tri-Tech, Inc. | 1990-09-17 | 199 | 0 |
| K823763 | VARIOUS-SPECIMEN COLLECTORS | Cordis Corp. | 1983-01-19 | 36 | 0 |
| K820180 | CALCULI FILTER CUP | Omnimedical | 1982-02-05 | 14 | 0 |
| K812933 | LANCER SPECIMEN CONTAINER | Sherwood Medical Co. | 1981-11-06 | 17 | 0 |
| K802340 | SPECIMEN SET | American Pharmaseal Div. Ahsc | 1980-10-10 | 14 | 0 |
| K802002 | URINE SPECIMEN CONTAINER #'S 1013-1016 | Pollak (Intl.), Ltd. | 1980-09-09 | 20 | 0 |
| K800947 | MIDSTREAM COLLECTION KIT | Sage Products, Inc. | 1980-05-30 | 38 | 0 |
| K800309 | SPECIMEN COLLECTION PAN | Sage Products, Inc. | 1980-02-26 | 14 | 0 |
| K800233 | ABCO MIDSTREAM URINE COLLECTION SET | Abco Dealers, Inc. | 1980-02-26 | 21 | 0 |
| K792710 | PARA-PAK CLEAN VIAL | Meridian Diagnostics, Inc. | 1980-01-28 | 32 | 2 |
| K792156 | LANCER SPECIMEN CONTAINER | Sherwood Medical Co. | 1979-12-10 | 42 | 0 |
| K792211 | SPECIMAN CUP & EMESIS BASIN | General Clinical Plastics Corp. | 1979-11-16 | 14 | 0 |
| K790915 | JUHN TYM-TAP | Xomed, Inc. | 1979-06-27 | 44 | 0 |
| K790291 | OPERATING ROOM SPECIMEN CONTAINER | Sage Products, Inc. | 1979-04-10 | 61 | 0 |
| K781557 | 24-HOUR URINE COLLECTION COOLING WRAP | Sage Products, Inc. | 1978-10-17 | 36 | 0 |
| K780057 | URINE SAMPLE COLLECTION KIT | C.R. Bard, Inc. | 1978-02-21 | 42 | 0 |
| K780167 | CATH KIT, URINE SPECIMEN | C.R. Bard, Inc. | 1978-02-21 | 19 | 0 |
| K780049 | SPECIMEN COLLECTION DEVICE | Urol, Inc. | 1978-01-26 | 17 | 0 |
| K770387 | UNICATCH | W.G. Whitney Corp. | 1977-04-05 | 36 | 0 |
| K770231 | MID-STREAM COLLECTION SET | Chesire Laboratories | 1977-03-30 | 51 | 0 |
| K770112 | SPECIMEN COLLECTOR | Portex, Inc. | 1977-03-14 | 54 | 0 |
| K761191 | 4 1/2 OZ. GRADUATED SPECIMEN CONTAINER | Superior Plastic Products Corp. | 1977-02-28 | 84 | 0 |
| K760496 | CUP, DISPOSABLE SPECIMEN | Landmark Plastics | 1976-11-12 | 81 | 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