Ranfac, Corp.: FDA clearances and approvals
Ranfac, Corp. has 16 FDA 510(k) clearances (first 1985, latest 2023), across 7 product codes in 3 review panels. Median 510(k) review time: 88 days. Since 2017 its median was 91 days, against 105 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 181 |
| 2014 | 1 | 147 |
| 2015 | 2 | 173 |
| 2016 | 0 | — |
| 2017 | 1 | 91 |
| 2018 | 0 | — |
| 2019 | 2 | 147 |
| 2020 | 1 | 37 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 78 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Ranfac, Corp.'s cleared 510(k)s took a median 91 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 105 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KNW | Instrument, Biopsy | 9 | 9 |
| MUU | System, Suction, Lipoplasty | 2 | 2 |
| FHO | Pneumoperitoneum Needle | 1 | 1 |
| GAA | Needle, Aspiration And Injection, Disposable | 1 | 1 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 | 1 |
| GDF | Guide, Needle, Surgical | 1 | 1 |
| HET | Laparoscope, Gynecologic (And Accessories) | 1 | 1 |
Review panels
Most recent Ranfac, Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K223612 | Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA) | KNW | 2023-02-21 | 78 |
| K202287 | Ran-Flex-B Bone Marrow Aspiration Needle | KNW | 2020-09-18 | 37 |
| K190177 | J-Type Marrow Biopsy Needle,T-Type Marrow Biopsy Needle,Tweezer Bone Marrow Biopsy Needle, | KNW | 2019-06-12 | 131 |
| K183146 | Ranfac Cartilage Biopsy Needle | KNW | 2019-04-25 | 163 |
| K162932 | Ranfac Fat Aspiration Cannula | MUU | 2017-01-19 | 91 |
| K150156 | Ranfac Fat Aspiration Transfer Syringe (FATS) Procedure Pack, Ranfac Fat Aspiration Transfer Syringe (FATS) Containment Vessel | MUU | 2015-10-19 | 269 |
| K150563 | Marrow Cellution Bone Marrow Aspiration Needle | KNW | 2015-05-22 | 77 |
| K140991 | RANFAC ASPIRATION NEEDLE WITH ADJUSTABLE GUIDE | KNW | 2014-09-11 | 147 |
| K131157 | RANFAC BONE MARROW ASPIRATION NEEDLE | KNW | 2013-10-22 | 181 |
| K031344 | RANFAC GOLDENBERG SNARECOIL SOFT TISSUE BIOPSY (GSS) NEEDLE | KNW | 2003-05-23 | 24 |
6 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Ranfac, Corp..
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 Ranfac, Corp. have?
Ranfac, Corp. has 16 FDA 510(k) clearances (first 1985, latest 2023), across 7 product codes in 3 review panels.
How long does FDA take to clear Ranfac, Corp.'s 510(k)s?
The median time from FDA receipt to decision across Ranfac, Corp.'s cleared 510(k)s is 88 days. Since 2017: 91 days, versus 105 days for all cleared 510(k)s in the same product codes.
What devices does Ranfac, Corp. make?
Its most frequent FDA product codes are KNW (Instrument, Biopsy, 9); MUU (System, Suction, Lipoplasty, 2); FHO (Pneumoperitoneum Needle, 1).
Has Ranfac, Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Ranfac, Corp. Related entities may recall under other names.
Next steps
- See all 16 Ranfac, Corp. clearances with predicates and recalls
- Run predicate analysis for product code KNW, Ranfac, Corp.'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.