Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Mark One Healthcare Products · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
62 daysmedian FDA review time
276 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K891986 | MULTIPLE-VARIOUS TYPES OF ABSORBENT INCONTINENCE | Mark One Healthcare Products | 1989-12-29 | 276 | 0 |
| K833867 | PAREMA K BAND NON-STERILE | Mark One Healthcare Products | 1984-01-27 | 81 | 0 |
| K833084 | MASTERHINGE | Mark One Healthcare Products | 1983-10-14 | 31 | 0 |
| K770396 | DRAPES, MODESTY | Mark One Healthcare Products | 1977-03-23 | 22 | 0 |
| K761268 | SKIN PRESSURE PROTECTORS | Mark One Healthcare Products | 1977-02-16 | 62 | 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