Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HAM — Predicate Candidate Screening
31 FDA 510(k) clearances under this product code; the 50 most recent screened below.
25 daysmedian FDA review time
90 days90th percentile
31clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K153472 | Quiver Laparoscopic Extendable | Itl Corporation Pty, Ltd. | 2016-06-23 | 204 | 0 |
| K000079 | NIKOPAD ELECTROSURGICAL GROUNDING PAD, MODEL 4777M | Nikomed U.S.A., Inc. | 2000-02-04 | 24 | 2 |
| K993306 | NIKOPAD ELECTROSURGICAL GROUNDING PAD (*OR SOLD UNDER COMMER | Paladin Medical, Inc. | 1999-11-03 | 30 | 0 |
| K945861 | BERGEN 710 ESU | Bergen Mfg. | 1995-03-01 | 90 | 0 |
| K913300 | LAPAROSTAT(TM) | Cook Ob/Gyn | 1992-04-02 | 252 | 0 |
| K920100 | GSU HANDPIECE ADAPTER | Beacon Laboratories, Inc. | 1992-02-03 | 25 | 0 |
| K911353 | EMC MODEL NO. STATOME 900 | Emc Industries | 1991-06-24 | 89 | 0 |
| K901248 | ABC HANDPIECE ADAPTER | Beacon Laboratories, Inc. | 1990-04-03 | 19 | 0 |
| K881334 | LIGHT COAGULATOR LC 250 | Nk-Optik GmbH | 1989-11-16 | 596 | 0 |
| K895337 | ELECTROSURGICAL COAGULATION SUCTION TUBE | New England Surgical Instrument Corp. | 1989-09-15 | 16 | 0 |
| K894663 | BEAMER ONE | Beacon Laboratories, Inc. | 1989-09-15 | 53 | 0 |
| K894762 | B100 DISPOSABLE HANDPIECE | Beacon Laboratories, Inc. | 1989-09-15 | 50 | 0 |
| K884171 | #875 DISPOSABLE BIOPOLAR CABLE | Olsen Electrosurgical, Inc. | 1988-10-24 | 24 | 0 |
| K884174 | MODIFIED OLSEN 755/756 SWITCHPENS | Olsen Electrosurgical, Inc. | 1988-10-24 | 24 | 0 |
| K884172 | MODIFIED OLSEN #770 DISPOSABLE HOLSTER | Olsen Electrosurgical, Inc. | 1988-10-24 | 24 | 0 |
| K884173 | #920 DISPOSABLE TUR CABLE | Olsen Electrosurgical, Inc. | 1988-10-24 | 24 | 0 |
| K884175 | #820/821 BIPOLAR FORCEPS | Olsen Electrosurgical, Inc. | 1988-10-24 | 24 | 0 |
| K871435 | BARD EMS SYSTEM 6000 E.S.U. | C.R. Bard, Inc. | 1987-05-11 | 28 | 1 |
| K863091 | BICORD BY QMED | Qmed, Inc. | 1986-08-29 | 16 | 0 |
| K853291 | GP-100 ADULT ELECTROSURGICAL GROUND PAD/200 & 300 | Bio-Detek, Inc. | 1985-10-10 | 66 | 0 |
| K852184 | ELECTRO-CAUTERY KNIFE CLEANER 6000 1 | Dlp, Inc. | 1985-06-04 | 15 | 0 |
| K833648 | OPHTHALMIC CAUTERY #6821-HOT-TEMP #'S | Edward Weck, Inc. | 1983-11-29 | 43 | 0 |
| K823755 | BICEPS ELECTROCAUTERY SYSTEM | Squibb Diagnostics | 1983-01-26 | 43 | 0 |
| K820664 | DISPOSABLE ELECTRODE | Trident Surgical Corp. | 1982-03-19 | 8 | 0 |
| K810920 | NDM DIATEMP INFANT ELECTROSURG. DISP. P. | Ndm Corp. | 1981-05-01 | 25 | 0 |
| K810909 | MICRO CAUTERY | Key Medical, Inc. | 1981-04-17 | 14 | 0 |
| K810015 | MULTIHI-TEMP CAUTERY | Medical Products Development, Inc. | 1981-02-12 | 38 | 0 |
| K810014 | REPLACABLE BATTERY HI-TEMP CAUTERY | Medical Products Development, Inc. | 1981-02-12 | 38 | 0 |
| K780293 | ELECTROSURGICAL UNIT | Ritter Co. | 1978-03-14 | 21 | 0 |
| K780118 | ELECTRODE, DISPERSIVE, DISP. NEOPAD | Neomed Corp. | 1978-02-23 | 31 | 0 |
| K771186 | MICRO BI-POLAR FORCEPS #39-200 | Edward Weck, Inc. | 1977-07-15 | 14 | 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