Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Peak Surgical, Inc. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
150 daysmedian FDA review time
266 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K103775 | PEAK SUCTION COAGULATOR | Peak Surgical, Inc. | 2011-05-27 | 151 | 0 |
| K102709 | PEAK PLASMABLADE PLUS TISSUE DISSECTION DEVICE | Peak Surgical, Inc. | 2010-12-17 | 88 | 0 |
| K102029 | PEAK PULSAR II GENERATOR MODEL PS100-102 | Peak Surgical, Inc. | 2010-12-16 | 150 | 0 |
| K093695 | PEAK PLASMABLADE 3.OS TISSUE DISSECTION DEVICE | Peak Surgical, Inc. | 2010-04-13 | 134 | 0 |
| K083415 | PEAK PLASMABLADE TNA TONSIL AND ADENOID TISSUE DISSECTION DE | Peak Surgical, Inc. | 2009-06-05 | 199 | 0 |
| K082786 | PULSAR GENERATOR, PEAK PLASMABLADE; 4.0, NEEDLE, AND EXT TIS | Peak Surgical, Inc. | 2008-12-03 | 71 | 1 |
| K073057 | PULSAR GENERATOR, MODEL PS100-100, AND PEAK PLASMABLADE TISS | Peak Surgical, Inc. | 2008-07-22 | 266 | 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