Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HDC — Predicate Candidate Screening
20 FDA 510(k) clearances under this product code; the 50 most recent screened below.
46 daysmedian FDA review time
260 days90th percentile
20clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K223866 | Carevix™ Suction Cervical Stabilizer | Aspivix SA | 2023-01-25 | 33 | 0 |
| K203820 | ASPIVIX v1.1 Cervical Suction Tenaculum | Aspivix SA | 2021-08-17 | 231 | 0 |
| K142204 | Bioceptive Suction Cervical Retractor | Bioceptive, Inc. | 2014-12-19 | 130 | 0 |
| K082349 | JARIT HULKA UTERINE TENACULUM FORCEPS | J. Jamner Surgical Instruments, Inc. | 2008-11-21 | 98 | 1 |
| K073182 | GYN DISPOSABLES TENACULUM 356T | Gyn-Disposables, Inc. | 2007-11-28 | 15 | 1 |
| K062563 | FEMTEN CERVICAL TENACULUM | Fem Suite, LLC | 2007-05-18 | 260 | 0 |
| K060573 | BURBANK TENACULUM | Vascular Control Systems, Inc. | 2006-04-21 | 46 | 0 |
| K032585 | TRANSVAGINAL ULTRASOUND PROBE HOLDER SYSTEM | Ron-Tech Medical , Ltd. | 2004-01-09 | 141 | 0 |
| K030078 | BURBANK TENACULUM, MODEL 09-0011-01 | Vascular Control Systems, Inc. | 2003-01-24 | 15 | 0 |
| K001818 | UTERINE TENACLUM HOOK | Towne Brothers (Pvt.), Ltd. | 2000-08-30 | 76 | 0 |
| K992071 | TRANSVAGINAL ULTRASOUND PROBE HOLDER DEVICE | Ron-Tech Medical , Ltd. | 1999-08-27 | 70 | 0 |
| K980247 | GYNEX IRIS HOOK, GYNEX ANGLE HOOK, GYNEX EMMETT TENACULUM | Gynex Corp. | 1998-03-17 | 53 | 0 |
| K930037 | ATRAUMATIC TENACULA | Thomasville Medical Assoc. | 1994-02-24 | 415 | 0 |
| K910287 | OTT CERVICAL TENACULUM | Marlo Surgical Technology | 1991-02-28 | 37 | 0 |
| K894891 | IRRIGATOR STAND | Commercial Products & Engineering Co. | 1989-08-23 | 22 | 0 |
| K891349 | CAMPION CERVICAL HOOK | Simpson/Basye, Inc. | 1989-03-29 | 19 | 0 |
| K891350 | NEWPORT CERVICAL MANIPULATOR | Simpson/Basye, Inc. | 1989-03-29 | 19 | 0 |
| K891347 | REID ENDOCERVICAL SPREADER | Simpson/Basye, Inc. | 1989-03-29 | 19 | 0 |
| K891033 | ATRAUMATIC TENACULA | Zinnanti Surgical Instruments, Inc. | 1989-03-17 | 17 | 0 |
| K890379 | UTERINE TENTACULUM | Kinetic Medical Products | 1989-02-13 | 21 | 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