Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Renu Medical, Inc. — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
146 daysmedian FDA review time
330 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K203847 | Reprocessed Tri Pulse Compression Garment | Renu Medical, Inc. | 2021-05-07 | 127 | 0 |
| K121145 | RENU MEDICAL REPROCESSED AIRCAST VENAFLOW CALF GARMENTS/ALL | Renu Medical, Inc. | 2012-06-12 | 57 | 0 |
| K111773 | RENU MEDICAL REPROCESSED OXIMAX SENSORS: ADULT, PEDIATRIC, I | Renu Medical, Inc. | 2011-11-16 | 146 | 0 |
| K093658 | RENU MEDICAL VASOPRESS CALF , THIGH GARMENTS- ALL SIZESD, RE | Renu Medical, Inc. | 2010-01-14 | 50 | 0 |
| K081927 | RENU MEDICAL OXIMETRY SENSOR, ADULT, PED, INF,NEO | Renu Medical, Inc. | 2009-02-06 | 214 | 0 |
| K072194 | RENU REPROCESSED NELLCOR OXIMETRY SENSOR, MODEL D-25, N-25 | Renu Medical, Inc. | 2007-11-29 | 114 | 0 |
| K063661 | RENU REPROCESSED NELLCOR OXYSENSOR, MODELS D-20 AND I-20 | Renu Medical, Inc. | 2007-05-25 | 168 | 0 |
| K051227 | RENU MEDICAL REPROCESSED ALP 1 CALF GARMENT, MODEL ALP1 | Renu Medical, Inc. | 2006-04-07 | 330 | 0 |
| K031559 | RENU MEDICAL REPORCESSED COMPRESSIBLE LIMB SLEEVES | Renu Medical, Inc. | 2003-11-12 | 177 | 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