Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
HCZ — Predicate Candidate Screening
24 FDA 510(k) clearances under this product code; the 50 most recent screened below.
72 daysmedian FDA review time
422 days90th percentile
24clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K172661 | Fetzer Medical Gynecological Forceps | Fetzer Medical GmbH & Co. KG | 2018-05-08 | 245 | 4 |
| K134047 | JARIT GYNECOLOGICAL FORCEPS, MILTEX GYNECOLOGICAL FORCEPS, M | Integra LifeSciences Corporation | 2014-04-11 | 101 | 0 |
| K092840 | INSTRUMED FORCEPS OBSTETRICAL/GYNAECOLOGICAL | Instrumed International, Inc. | 2009-12-03 | 79 | 0 |
| K944055 | FORCEPS, SURGICAL GYNECOLOGICAL | Owens Precision Systems, Inc. | 1994-09-20 | 32 | 0 |
| K941528 | PEARL PACKING FORCEPS | Cook Urological, Inc. | 1994-05-12 | 43 | 0 |
| K926484 | CORSON MYOMA GRASPING FORCEPS | Thomasville Medical Assoc. | 1994-02-25 | 423 | 0 |
| K926533 | Z-CLAMP FORCEPS | Thomasville Medical Assoc. | 1994-02-25 | 422 | 0 |
| K926531 | HYSTERECTOMY FORCEPS | Thomasville Medical Assoc. | 1994-02-25 | 422 | 0 |
| K930799 | VARIOUS FORCEPS | Thomasville Medical Assoc. | 1994-02-24 | 373 | 0 |
| K926528 | OVUM FORCEPS | Thomasville Medical Assoc. | 1994-02-24 | 421 | 0 |
| K930039 | FORCEPS: MCGRAVEY, MCINDOE, GILLIS | Thomasville Medical Assoc. | 1994-02-24 | 415 | 0 |
| K911474 | LAPAROSCOPIC FORCEPS | United States Endoscopy Group, Inc. | 1991-07-03 | 90 | 0 |
| K903707 | DEFLECTING WIRE GRASPER | Cook, Inc. | 1990-09-26 | 42 | 0 |
| K901897 | ZEPPELIN FORCEPS | Kirwan Surgical Products, Inc. | 1990-06-29 | 65 | 0 |
| K892820 | FORCEPS, SURGICAL, GYNECOLOGICAL | The South India Surgical Co. Pvt. , Ltd. | 1989-06-22 | 72 | 0 |
| K891036 | HYSTERECTOMY FORCEPS - (SEVERAL MODELS) | Zinnanti Surgical Instruments, Inc. | 1989-03-17 | 17 | 0 |
| K891047 | ZEPPELIN FORCEPS | Zinnanti Surgical Instruments, Inc. | 1989-03-17 | 17 | 0 |
| K890383 | HYSTERECTOMY FORCEPS | Kinetic Medical Products | 1989-02-16 | 24 | 0 |
| K890386 | PLACENTA AND OVUM FORCEPS | Kinetic Medical Products | 1989-02-13 | 21 | 0 |
| K890378 | UTERINE DRESSING FORCEPS | Kinetic Medical Products | 1989-02-13 | 21 | 0 |
| K852721 | BOZEMAN UTERINE FORCEPS, STRAIGHT, 10+410 0R 420 | The Huxley Instrument Corp. | 1985-09-06 | 72 | 0 |
| K834174 | OP-CON SURGICAL INSTRUMENTS #4 | Imm Enterprises , Ltd. | 1983-12-27 | 36 | 0 |
| K810391 | VOGLER HYSTERECTOMY FORCEPS (SMALL & LG) | Edward Weck, Inc. | 1981-03-04 | 15 | 0 |
| K772229 | MINICLAMPS, STABILIZ., FALLOPIAN TUBE | J. Sklar Mfg. Co., Inc. | 1978-01-03 | 28 | 5 |
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