Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HDQ — Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
43 daysmedian FDA review time
415 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K930034 | CERVICAL DILATORS:PRATT,HAWKIN,KLEEGMAN,DENNISTON | Thomasville Medical Assoc. | 1994-02-24 | 415 | 0 |
| K896701 | TEFLON CERVICAL ACCESS SET | Cook Ob/Gyn | 1990-09-13 | 289 | 0 |
| K891029 | CERVICAL DILATORS PRATT,HAWKIN,KLEEGMAN,DENN.,VALL | Zinnanti Surgical Instruments, Inc. | 1989-03-17 | 17 | 0 |
| K890377 | FIXED-SIZE UTERINE DILATOR | Kinetic Medical Products | 1989-02-13 | 21 | 0 |
| K811568 | CERVICAL DILATOR | Gynemetrics, Inc. | 1981-07-16 | 42 | 0 |
| K791277 | MODEL 6500 EXTRACTION IRRIGATION SYS | Cavitron Corp. | 1979-08-22 | 43 | 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