Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HFB — Predicate Candidate Screening
22 FDA 510(k) clearances under this product code; the 50 most recent screened below.
96 daysmedian FDA review time
527 days90th percentile
22clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K011488 | SPIRABRUSH CX BIOPSY INSTRUMENT | Trylon Corp. | 2002-02-22 | 283 | 0 |
| K944444 | CIT BIOPSY PUNCHES | Chirurgische Instrumente | 1995-09-29 | 413 | 0 |
| K930773 | SYMBIOSIS GYNECOLOGICAL BIOPSY FORCEPS | Symbiosis Corp. | 1994-07-28 | 527 | 0 |
| K933767 | FORCEPS, BIOPSY GYNECOLOGICAL INSTRU/BIOPSY | Mahe-Medizintechnik | 1994-05-26 | 301 | 0 |
| K926595 | OWENS BIOPSY FORCEPS | Owens Industries, Inc. | 1994-05-25 | 623 | 0 |
| K926527 | ROTO FIT BIOPSY FORCEPS | Thomasville Medical Assoc. | 1994-02-25 | 422 | 0 |
| K930036 | THOMAS MEDICAL BIOPSY FORCEPS | Thomasville Medical Assoc. | 1994-02-24 | 415 | 0 |
| K926538 | TISCHLER BIOPSY FORCEPS | Thomasville Medical Assoc. | 1994-02-24 | 421 | 0 |
| K924224 | OWENS BIOPSY FORCEPS | Owens Precision Systems, Inc. | 1994-02-04 | 532 | 0 |
| K902049 | CROAK OVARIAN BIOPSY FORCEP | Gynescope Corp. | 1990-06-07 | 31 | 0 |
| K895303 | EVER-SHARP BIOPSY FORCEPS | Southwest Medical Mfg., Inc. | 1990-01-16 | 140 | 0 |
| K891043 | ROTO FIT BIOPSY FORCEPS | Zinnanti Surgical Instruments, Inc. | 1989-03-22 | 22 | 0 |
| K891034 | TISCHLER BIOPSY FORCEPS | Zinnanti Surgical Instruments, Inc. | 1989-03-17 | 17 | 0 |
| K891027 | ZSI BIOPSY FORCEPS | Zinnanti Surgical Instruments, Inc. | 1989-03-17 | 17 | 0 |
| K890380 | CERVICAL BIOPSY FORCEPS | Kinetic Medical Products | 1989-02-27 | 35 | 0 |
| K852357 | GYNE-SHEAR CERVICAL BIOPSY INSTRUMENT W/DISPIS TIP | Gyneco, Inc. | 1985-07-05 | 32 | 0 |
| K851110 | GAYLOR-THOMS UTERINE BIOPSY FORCEPS 1810-144 PCS. | The Huxley Instrument Corp. | 1985-04-08 | 20 | 0 |
| K842112 | TISCHLER CERVICAL BIOPSY PUNCH FORCEPS | J. Sklar Mfg. Co., Inc. | 1984-07-03 | 35 | 0 |
| K840352 | CIN-SHEAR | Roland J. Zwick, Inc. | 1984-04-05 | 70 | 0 |
| K820519 | BIOPSER | Advanced Biomedical Instruments | 1982-04-29 | 63 | 0 |
| K802458 | KEVORKIAN-YOUNGE BIOPSY CURETTE #90-6611 | J. Sklar Mfg. Co., Inc. | 1981-01-12 | 96 | 1 |
| K802457 | KEVORKIAN-YOUNGE BIOPSY PUNCH, #90-6610 | J. Sklar Mfg. Co., Inc. | 1981-01-12 | 96 | 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