Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ultracision, Inc. · Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
241 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K952726 | ULTRACISION HARMONIC SCAPEL | Ultracision, Inc. | 1995-06-23 | 9 | 0 |
| K941897 | ULTRACISON HARMONIC SCALPEL HS2 BLADE | Ultracision, Inc. | 1994-07-01 | 74 | 0 |
| K930352 | HARMONIC SCALPEL REUSABLE LAPORASCOPIC BLADE SYST. | Ultracision, Inc. | 1993-06-08 | 138 | 0 |
| K924917 | HARMONIC SCALPEL 5MM LAPAROSONIC BLADE ACCESSORY | Ultracision, Inc. | 1993-05-21 | 234 | 0 |
| K925699 | HARMONIC SCALPEL LAPAROSONIC CLAMP COAGULATOR ACC. | Ultracision, Inc. | 1993-05-17 | 186 | 0 |
| K924281 | HARMONIC SCALPEL LAPAROSONIC BLADE ACCESSORY | Ultracision, Inc. | 1993-04-23 | 241 | 0 |
| K911341 | HARMONIC SCALPEL ENDOSCOPIC BLADE COUPLER EXTENSIO | Ultracision, Inc. | 1991-06-24 | 90 | 0 |
| K905315 | ULTRACISION HARMONIC SCALPEL | Ultracision, Inc. | 1991-02-15 | 79 | 0 |
| K895252 | ULTRACISION ULTRASONIC SCALPEL | Ultracision, Inc. | 1989-10-31 | 71 | 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