Renu Medical, Inc.: FDA clearances and approvals
Renu Medical, Inc. has 9 FDA 510(k) clearances (first 2003, latest 2021), across 2 product codes in 2 review panels. Median 510(k) review time: 146 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 57 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 127 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Renu Medical, Inc.'s cleared 510(k)s took a median 127 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 133 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JOW | Sleeve, Limb, Compressible | 5 | 5 |
| NLF | Oximeter, Reprocessed | 4 | 4 |
Review panels
- Cardiovascular (5)
- Anesthesiology (4)
Most recent Renu Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K203847 | Reprocessed Tri Pulse Compression Garment | JOW | 2021-05-07 | 127 |
| K121145 | RENU MEDICAL REPROCESSED AIRCAST VENAFLOW CALF GARMENTS/ALL SIZES, RENU MEDICAL REPROCESSED AIRCAST VENAFLOW THIGH GARME | JOW | 2012-06-12 | 57 |
| K111773 | RENU MEDICAL REPROCESSED OXIMAX SENSORS: ADULT, PEDIATRIC, INFANT AND NEONATE | NLF | 2011-11-16 | 146 |
| K093658 | RENU MEDICAL VASOPRESS CALF , THIGH GARMENTS- ALL SIZESD, RENU MEDICAL VASOPRESS FOOT GARMENTS | JOW | 2010-01-14 | 50 |
| K081927 | RENU MEDICAL OXIMETRY SENSOR, ADULT, PED, INF,NEO | NLF | 2009-02-06 | 214 |
| K072194 | RENU REPROCESSED NELLCOR OXIMETRY SENSOR, MODEL D-25, N-25 | NLF | 2007-11-29 | 114 |
| K063661 | RENU REPROCESSED NELLCOR OXYSENSOR, MODELS D-20 AND I-20 | NLF | 2007-05-25 | 168 |
| K051227 | RENU MEDICAL REPROCESSED ALP 1 CALF GARMENT, MODEL ALP1 | JOW | 2006-04-07 | 330 |
| K031559 | RENU MEDICAL REPORCESSED COMPRESSIBLE LIMB SLEEVES | JOW | 2003-11-12 | 177 |
Recalls
openFDA lists no recalls under a recalling firm named Renu Medical, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Renu Medical, Inc. have?
Renu Medical, Inc. has 9 FDA 510(k) clearances (first 2003, latest 2021), across 2 product codes in 2 review panels.
How long does FDA take to clear Renu Medical, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Renu Medical, Inc.'s cleared 510(k)s is 146 days.
What devices does Renu Medical, Inc. make?
Its most frequent FDA product codes are JOW (Sleeve, Limb, Compressible, 5); NLF (Oximeter, Reprocessed, 4).
Has Renu Medical, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Renu Medical, Inc. Related entities may recall under other names.
Next steps
- See all 9 Renu Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JOW, Renu Medical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.