Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Heraeus Surgical, Inc. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
88 daysmedian FDA review time
225 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K960636 | LASERSONICS ND:YAG CYLINDRICALLY DIFFUSING STERILE DISPOSABL | Heraeus Surgical, Inc. | 1996-08-21 | 189 | 0 |
| K955734 | LASERSONICS PARASCAN DOSIMETER DEVICE | Heraeus Surgical, Inc. | 1996-02-13 | 57 | 0 |
| K953917 | LASESONICS LOW POWER CO2 LASER SYSTEM | Heraeus Surgical, Inc. | 1995-10-26 | 66 | 0 |
| K951215 | LASERSONICS ULTRALINE III STERILE DISPOSABLE FIBER | Heraeus Surgical, Inc. | 1995-04-18 | 32 | 0 |
| K943716 | LASERSONICS SURGICAL LASER SYSTEMS AND ACCESSORIES | Heraeus Surgical, Inc. | 1995-03-14 | 225 | 0 |
| K944346 | LASERSONICS RADIANCE DIODE LASER SYSTEMS AND ACCESSORIES | Heraeus Surgical, Inc. | 1994-11-08 | 63 | 0 |
| K935604 | LASERSONICS TISSUE MORCELLATOR SET | Heraeus Surgical, Inc. | 1994-03-23 | 124 | 0 |
| K935775 | LASERSONICS CLEARPULSE MODELS 50, 70 & 100 CO2 SURGICAL LASE | Heraeus Surgical, Inc. | 1994-03-01 | 88 | 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