Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
GEN — Predicate Candidate Screening
104 FDA 510(k) clearances under this product code; the 50 most recent screened below.
25 daysmedian FDA review time
59 days90th percentile
104clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K031828 | NATURALASE LP ND:YAG LASER | Focus Medical, LLC | 2003-07-17 | 34 | 0 |
| K953962 | FORCEPS | Biopsys Medical, Inc. | 1995-09-08 | 17 | 0 |
| K932385 | SUTURE REMOVING FORCEPS | Rocket of London, Ltd. | 1993-08-06 | 81 | 0 |
| K904723 | FORCEPS | Minto Research & Development, Inc. | 1991-07-26 | 282 | 0 |
| K911159 | PALPATION PROBE | Northgate Technologies, Inc. | 1991-03-29 | 14 | 0 |
| K900948 | GS-1002 GRASPING FORCEP, 5MM WITH RATCHET | Solos Endoscopy, Inc. | 1990-04-18 | 50 | 0 |
| K900960 | GS-1500 CLAW FORCEP, 10MM | Solos Endoscopy, Inc. | 1990-04-18 | 50 | 0 |
| K900952 | GS-1200 GRASPING/EXTRACTING FORCEP, 10MM | Solos Endoscopy, Inc. | 1990-04-18 | 50 | 0 |
| K900951 | GS-7000 CLIP-APPLYING FORCEP, 10MM, MEDIUM CLIP | Solos Endoscopy, Inc. | 1990-04-18 | 50 | 0 |
| K891896 | TISSUE FORCEPS, VARIOUS TYPES | Zinnanti Surgical Instruments, Inc. | 1989-04-12 | 19 | 0 |
| K891401 | HEMOSTATIC FORCEPS BRUNS.,GEMINI,SPENCER-WELL,KANT | Zinnanti Surgical Instruments, Inc. | 1989-04-06 | 23 | 0 |
| K891348 | CAMPION LASER FORCEPS | Simpson/Basye, Inc. | 1989-03-22 | 12 | 0 |
| K884514 | FORCEPS, TOWEL, BACKHAUS-TSK (BRAND) TOWEL | Gatewood and Associates, Ltd. | 1988-11-17 | 21 | 0 |
| K884181 | MANUAL SURGICAL INSTRUMENTS (SEVERAL MODELS) | Sales & Marketing Assoc. | 1988-11-10 | 38 | 0 |
| K884195 | GENERAL SURGICAL INSTRUMENTS (VARIOUS TYPES) | Mumtaz I. Malik | 1988-10-24 | 18 | 0 |
| K875319 | NSN #6515-00-690-3209 DEBAKEY TISSUE FORCEPS | I-Tech Industries, Inc. | 1988-01-22 | 24 | 0 |
| K874634 | NSN #6515-00-333-2400 ADSON DRESSING FORCEPS | I-Tech Industries, Inc. | 1987-12-02 | 22 | 0 |
| K873978 | DISPOSABLE BIPOLAR FORCEPS | E.M. Adams | 1987-11-23 | 54 | 0 |
| K872991 | MICRINS FORCEPS 2010 | Micrins Surgical, Inc. | 1987-08-17 | 17 | 0 |
| K872271 | VARIOUS SIZES & STYLES OF MONOPOLAR FORCEPS | New England Surgical Instrument Corp. | 1987-06-26 | 14 | 0 |
| K871926 | GRASPING FORCEP, 1.7MM | Arthropedics, Inc. | 1987-06-09 | 22 | 0 |
| K871927 | CUP BIOPSY FORCEP, 1.7MM | Arthropedics, Inc. | 1987-06-09 | 22 | 0 |
| K864608 | ADOBE ENTERPRISES SURGICAL/BANDAGE SCISSORS FORCEP | Adobe Ent. | 1986-12-16 | 22 | 0 |
| K861805 | MEDCARE FORCEPS (THUMB, TISSUE) | Medcomp Technologies, Inc. | 1986-05-23 | 14 | 0 |
| K854916 | PILLING HEMOSTATIC CLIP APPLIER FORCEPS | Pilling Co. | 1986-01-24 | 46 | 0 |
| K854541 | TIP OFF FORCEPS | Keller Instruments, Inc. | 1985-12-17 | 34 | 0 |
| K854146 | SURGICAL & DENTAL INSTRUMENT | Baort, Inc. | 1985-11-13 | 33 | 0 |
| K853153 | MEDUS GMBH | Corkes Medical Co. | 1985-08-07 | 9 | 0 |
| K853015 | SELF-CENTERING BONE HOLDING FORCEPS, 10-1/4 SS420 | The Huxley Instrument Corp. | 1985-07-29 | 12 | 0 |
| K852730 | CRILE FORCEPS, STRIAGHT, 6-1/4+SS 410 OR 420 | The Huxley Instrument Corp. | 1985-07-15 | 19 | 0 |
| K852717 | IRIS FORCEPS, DELICATE, 1X2 TEETH, STRAIGHT, 4XSS | The Huxley Instrument Corp. | 1985-07-15 | 19 | 0 |
| K852120 | FORCEPS, BIOPSY(NON RIGID) | Scholten Surgical Instruments, Inc. | 1985-07-02 | 48 | 0 |
| K851728 | 2250/1 TO 2285/2 VARIOUS COTTON TWEEZERS | Artiberia | 1985-07-01 | 67 | 0 |
| K852531 | NON-PERFORATING TOWEL FORCEPS-5-1/4 IN SS 410 | The Huxley Instrument Corp. | 1985-06-28 | 14 | 0 |
| K851796 | 51-210 TO 51-352 VARIOUS INTEST FOR CALLIS, LOCKWO | Artiberia | 1985-06-20 | 56 | 0 |
| K851773 | 17-280,17-576 HAEMOSTATIC FORCEPS SPENCERUELLS, KI | Artiberia | 1985-06-20 | 56 | 0 |
| K851771 | 15-490 TO 15-520 VARIOUS SPLINTER FORCEPS PEET, ST | Artiberia | 1985-06-20 | 56 | 0 |
| K851772 | 17-100,17-272 VARIOUS HAEMOSTATIC FORCEPS | Artiberia | 1985-06-20 | 56 | 0 |
| K851793 | 39-260 TO 39-299 VARIOUS FOREIGN BODY FORCEPS | Artiberia | 1985-06-20 | 56 | 0 |
| K851673 | RAKA OCH BOSDA PEANGER | General Electric Trading Co. | 1985-05-29 | 36 | 0 |
| K851106 | PRATT-SMITH T FORCEPS 1830-40 PCS. SS 420 OR 420F | The Huxley Instrument Corp. | 1985-04-25 | 37 | 0 |
| K851114 | MAGILL FORCEPS 1711-46 PCS. SS 410 OR 420 | The Huxley Instrument Corp. | 1985-04-25 | 37 | 0 |
| K851170 | DISSECTING TWEEZER #283-72PCS. SS 410 | The Huxley Instrument Corp. | 1985-04-25 | 34 | 0 |
| K851116 | JUDD-AILLIS TISSUE FORCEPS 1820-118 PCS. SS 410/42 | The Huxley Instrument Corp. | 1985-04-25 | 37 | 0 |
| K844062 | FORCEPS & HAMOSTATS | I M, Inc. | 1985-01-18 | 92 | 0 |
| K843074 | DISPOS. & SPONGE FORCEPS PEAN ARTERY | Greene International Corp. | 1984-08-17 | 11 | 0 |
| K834095 | BIOPSY FORCEPS | Micro Vasive, Inc. | 1984-01-27 | 60 | 0 |
| K833542 | SURGICAL INSTRUMENT | Hirata Sangyo Co. USA, Inc. | 1983-11-28 | 62 | 0 |
| K831805 | GENERAL SURGICAL INSTRUMENTS | Aim Corp. | 1983-07-14 | 38 | 0 |
| K822591 | TISSUE FORCEPS | Medcare Products | 1982-10-13 | 35 | 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