Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Permobil AB — Predicate Candidate Screening
15 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
147 daysmedian FDA review time
415 days90th percentile
15clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K190682 | Explorer Mini | Permobil AB | 2020-02-27 | 346 | 0 |
| K191874 | F5 Corpus VS | Permobil AB | 2019-10-25 | 105 | 0 |
| K143180 | F3 | Permobil AB | 2015-03-27 | 143 | 0 |
| K143014 | F5 | Permobil AB | 2015-03-25 | 156 | 0 |
| K123290 | M300 & M400 | Permobil AB | 2013-04-17 | 177 | 2 |
| K103477 | PERMOBIL M300 / M400 | Permobil AB | 2011-03-03 | 97 | 0 |
| K081964 | K450 POWERED WHEELCHAIR | Permobil AB | 2008-07-29 | 19 | 0 |
| K071650 | C350 POWERED WHEELCHAIR | Permobil AB | 2007-09-12 | 86 | 2 |
| K041219 | ELECTRO | Permobil AB | 2004-08-04 | 86 | 3 |
| K032765 | STREET | Permobil AB | 2004-01-30 | 147 | 0 |
| K993406 | TRAX, POWERED WHEELCHAIR, MODEL 308686-00-0 | Permobil AB | 2000-12-18 | 437 | 0 |
| K991658 | PERMOBIL POWERED WHEELCHAIR 1280 | Permobil AB | 1999-10-08 | 147 | 4 |
| K960951 | PERMOBIL CHAIRMAN L/CS 8 | Permobil AB | 1997-04-30 | 415 | 0 |
| K942508 | ROBO | Permobil AB | 1994-11-07 | 165 | 0 |
| K902954 | OBER2 MONITOR, EYE MOVEMENT (OPHTHALMIC) | Permobil AB | 1990-08-23 | 49 | 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