Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medical Flotation Systems, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
34 daysmedian FDA review time
112 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K893801 | M.F.S. LOW AIR LOSS PULSATING BED | Medical Flotation Systems, Inc. | 1989-07-25 | 64 | 0 |
| K890200 | PNEUMATIC DORSIFLEXOR | Medical Flotation Systems, Inc. | 1989-02-03 | 16 | 0 |
| K884908 | ULTRAFLOTATION MEDICAL WHEELCHAIR | Medical Flotation Systems, Inc. | 1988-12-27 | 34 | 0 |
| K884907 | BUMPY MEDICAL MASSAGE MAT | Medical Flotation Systems, Inc. | 1988-12-27 | 34 | 0 |
| K882607 | ULTRAFLOTATION BED | Medical Flotation Systems, Inc. | 1988-10-14 | 112 | 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