Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FZW — Predicate Candidate Screening
8 FDA 510(k) clearances under this product code; the 50 most recent screened below.
100 daysmedian FDA review time
169 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K080158 | LB MEDICAL INFLATABLE TISSUE ELEVATOR/EXPANDER SYSTEM | Lb Medical LLC | 2008-05-02 | 100 | 0 |
| K984448 | BIRCOLL BALLOON DISSECTOR | Wells Johnson Co. | 1999-01-28 | 45 | 0 |
| K972109 | SPACEMAKER SURGICALBALLOON DISSECTOR/EXPANDER | General Surgical Innovations | 1997-11-14 | 162 | 0 |
| K936186 | AESCULAP SKIN GRAFT MESHER | Aesculap, Inc. | 1994-03-10 | 77 | 0 |
| K904265 | INAMED RUIZ-COHEN INTRAOPERATIVE TISSUE EXPANDER | Inamed Development Co. | 1991-03-06 | 169 | 0 |
| K902349 | SURGITEK INTRA-SPAN INTRAOPERATIVE TISSUE EXPANDER | Surgitek | 1990-09-05 | 103 | 0 |
| K883303 | MENTOR RAPID-SPAN (TM) TISSUE EXPANDER | Mentor Corp. | 1988-08-26 | 22 | 0 |
| K874276 | CUI, VERSAFIL(TM), STE(TM) TISSUE EXPANDER | Cox-Uphuff Intl. | 1987-12-02 | 43 | 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