Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Unimed Surgical Products, Inc. · Predicate Candidate Screening
13 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
36 daysmedian FDA review time
246 days90th percentile
13clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K132224 | UNIMED SURGICAL COATED ELECTROSURGICAL ELECTRODES | Unimed Surgical Products, Inc. | 2013-10-08 | 83 | 0 |
| K993647 | UNIMED DISPOSABLE HAND AND FOOT-SWITCHING PENCILS WITH HOLST | Unimed Surgical Products, Inc. | 1999-11-16 | 18 | 0 |
| K970066 | UNIMED COATED LAPAROSCOPIC/ARTHROSCOPY/SUCTION-IRRIGATION EL | Unimed Surgical Products, Inc. | 1997-02-18 | 41 | 1 |
| K963338 | UNIMED SUCTION-IRRIGATION ELECTRODE AND SLIDING SHEATH | Unimed Surgical Products, Inc. | 1996-10-21 | 59 | 0 |
| K962935 | UNIMED COATED NEEDLE ELECTRODE/COATED BLADE ELECTRODE/COATED | Unimed Surgical Products, Inc. | 1996-09-03 | 36 | 13 |
| K944450 | SURGI-LINK LLETZ NEEDLE ELECTRODE, LOOP ELECTRODE, SQUARE LO | Unimed Surgical Products, Inc. | 1995-07-25 | 316 | 0 |
| K944265 | NEEDLE ELCTRODE | Unimed Surgical Products, Inc. | 1995-05-05 | 246 | 11 |
| K946246 | SURGI-LINK BIPOLAR MICRO FORCEPS | Unimed Surgical Products, Inc. | 1995-03-07 | 75 | 0 |
| K945030 | SURGI-LINK LAPAROSCOPIC ELECTRODES | Unimed Surgical Products, Inc. | 1994-11-03 | 21 | 0 |
| K944898 | SURGI-LINK BIPOLAR ELECTRODES | Unimed Surgical Products, Inc. | 1994-11-01 | 28 | 0 |
| K944617 | SURGI-LINK DISPOSABLE PUSH BUTTON ESU PENCIL | Unimed Surgical Products, Inc. | 1994-09-29 | 9 | 0 |
| K944433 | SURGI-LINK ELECTROSURGICAL ELECTRODE | Unimed Surgical Products, Inc. | 1994-09-26 | 14 | 0 |
| K944045 | SURGI-LINK ENDOSCOPIC BIPOLAR FORCEPS | Unimed Surgical Products, Inc. | 1994-09-08 | 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