Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ritmed, Inc. — Predicate Candidate Screening
22 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
104 daysmedian FDA review time
134 days90th percentile
22clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K833626 | FLORET FOAM PREP SPONGE | Ritmed, Inc. | 1984-02-17 | 126 | 0 |
| K832874 | ISOVIS WOUND PROTECTOR | Ritmed, Inc. | 1983-09-26 | 34 | 0 |
| K830270 | ISOVIS WOUND PROTECTOR | Ritmed, Inc. | 1983-06-24 | 150 | 0 |
| K830261 | FLORET STRUNG GAUZE SPONGES | Ritmed, Inc. | 1983-06-08 | 134 | 0 |
| K830267 | FLORET SPECIAL GAUZE SPONGES | Ritmed, Inc. | 1983-06-08 | 134 | 0 |
| K830268 | FLORET CYLINDRICAL/BRONCHOSCOPIC/LAMIN | Ritmed, Inc. | 1983-06-08 | 134 | 0 |
| K830266 | FLORET KITTNER OR K DISSECTOR | Ritmed, Inc. | 1983-06-08 | 134 | 0 |
| K830264 | FLORET TONSIL & ADENOID SPONGES | Ritmed, Inc. | 1983-06-03 | 129 | 0 |
| K830272 | PROTET HOLDERS-BLOCKS & ROLL | Ritmed, Inc. | 1983-06-03 | 129 | 0 |
| K830269 | FLORET NEURO SPONGE | Ritmed, Inc. | 1983-06-02 | 128 | 2 |
| K830271 | LAPET & LAPWALL LAPAROTOMY SPONGES | Ritmed, Inc. | 1983-06-02 | 128 | 0 |
| K830259 | PROTET SOAP & WASH MITT | Ritmed, Inc. | 1983-05-09 | 104 | 0 |
| K830262 | FLORET OPHTHALMIC EYE SPEAR | Ritmed, Inc. | 1983-04-06 | 71 | 0 |
| K830265 | FLORET DRAIN/TRACHEOTOMY SPONGE | Ritmed, Inc. | 1983-03-29 | 63 | 0 |
| K830278 | FLORET GAUZE PACKING | Ritmed, Inc. | 1983-03-29 | 63 | 0 |
| K830276 | SECURET DRAPE & INSTRUMENT RETAINER/INCL | Ritmed, Inc. | 1983-03-29 | 63 | 0 |
| K830263 | FLORET NASAL TAMPON | Ritmed, Inc. | 1983-03-24 | 58 | 0 |
| K830260 | FLORET VAGINAL PACKING/TAMPONS | Ritmed, Inc. | 1983-03-17 | 51 | 0 |
| K830274 | FLORET PEANUT SPONGE/STICK & GAUZE PREP | Ritmed, Inc. | 1983-03-08 | 42 | 0 |
| K830275 | NEEDELET HANDLER FOR SHARPS | Ritmed, Inc. | 1983-03-08 | 42 | 0 |
| K830277 | DUOWIPE CAUTERY TIP & INSTRUMENT CLEANER | Ritmed, Inc. | 1983-03-08 | 42 | 0 |
| K830273 | COUNTWAY SYS. SOILED SPONGES-BLOOD LOS | Ritmed, Inc. | 1983-02-28 | 34 | 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