Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HFC — Predicate Candidate Screening
11 FDA 510(k) clearances under this product code; the 50 most recent screened below.
82 daysmedian FDA review time
187 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K974032 | ROCKET MUCUS SAMPLER SYRINGE, STERILE, ROCKET MUCUS SAMPLER | A & A Medical, Inc. | 1997-12-22 | 60 | 0 |
| K960263 | CERVICAL MUCOUS ASPIRATION CATHETER | Cook Urological, Inc. | 1996-08-29 | 224 | 0 |
| K954903 | PEDI VAGINAL ASPIRATOR | Cook Urological, Inc. | 1996-04-29 | 187 | 0 |
| K954102 | SELECTMUCUS | Select Medical Systems, Inc. | 1995-11-21 | 82 | 0 |
| K902242 | ENDOCERVICAL ASPIRATOR | Innovative Medical Products, Inc. | 1990-10-09 | 144 | 0 |
| K902032 | O. B. PACK IV | Customed, Inc. | 1990-09-28 | 147 | 2 |
| K902954 | OBER2 MONITOR, EYE MOVEMENT (OPHTHALMIC) | Permobil AB | 1990-08-23 | 49 | 0 |
| K895403 | ASPIRETTE ENDOCERVICAL ASPIRATOR | Unimar, Inc. | 1989-11-29 | 83 | 0 |
| K821134 | DC PACK TM | Seamless Hospital Products Co. | 1982-06-22 | 63 | 0 |
| K812175 | ENDOCERVICAL ASPIRATOR | Fertility Instrumentation, Inc. | 1981-09-21 | 49 | 0 |
| K801238 | ACCU-PAP T ZONE SAMPLER | Robert Hasselbrack, M.D. | 1980-08-12 | 77 | 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