Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Fibra Sonics, Inc. — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
88 daysmedian FDA review time
207 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K993046 | FIBRA SONICS ULTRASONIC LITHOTRIPTOR LITHOSONIC, MODEL LS-20 | Fibra Sonics, Inc. | 1999-11-22 | 73 | 0 |
| K984199 | EXONIX | Fibra Sonics, Inc. | 1999-02-17 | 85 | 0 |
| K984143 | FIBRA-SONICS PHACO III OR IIIP FRAGMENTATION SYSTEM | Fibra Sonics, Inc. | 1999-02-16 | 90 | 0 |
| K983199 | FIBRA SONICS ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL 100 | Fibra Sonics, Inc. | 1998-12-14 | 91 | 0 |
| K980930 | FIBRA SONICS ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL 210 | Fibra Sonics, Inc. | 1998-09-22 | 194 | 0 |
| K842024 | ULTRASONIC LITHOTRIPTOR 300A | Fibra Sonics, Inc. | 1984-12-11 | 207 | 0 |
| K834453 | PHACO FRAGMENTOR GT-1 | Fibra Sonics, Inc. | 1984-03-16 | 88 | 0 |
| K813389 | ULTRASONIC FRAGMENTOR | Fibra Sonics, Inc. | 1982-02-04 | 63 | 0 |
| K812909 | HYGIENTIST; CYCLOSON I & II; RETROFIT | Fibra Sonics, Inc. | 1981-12-14 | 56 | 0 |
| K802381 | LEWICKY ANTERIOR CHAMBER MAINTEN. SYS. | Fibra Sonics, Inc. | 1980-12-17 | 79 | 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