Distronic Sterile Products, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Distronic Sterile Products, Inc.” (first 1995, latest 1996), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 74 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | 5 | 5 |
| FPK | Tubing, Fluid Delivery | 2 | 2 |
| FMG | Stopcock, I.V. Set | 1 | 1 |
Review panels
- General Hospital (8)
Most recent Distronic Sterile Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K955732 | VENTED SOLUTION SET | FPA | 1996-02-21 | 64 |
| K955709 | WINGED & SUBCUTANEOUS INFUSION SETS | FPA | 1996-02-21 | 65 |
| K954984 | MINIBORE STOPCOCK SET | FMG | 1996-01-23 | 84 |
| K954983 | EXTENSION SET WITH CHECK VALVE | FPA | 1996-01-23 | 84 |
| K952664 | SOLUTION ADMINISTRATION SET | FPA | 1995-08-07 | 56 |
| K950597 | CORE-RESISTANT HUBER INFUSION SET WITH Y-SITE | FPA | 1995-07-26 | 167 |
| K952663 | 60 MICRO VOLUME EXTENSION SET W/.22 MICRON FILTER, 21 EXTENSION SET W/1.2 MIVTON GILYRT, INJ. SITE, CLAMP | FPK | 1995-07-14 | 32 |
| K945184 | INTRAVASCULAR ADMINISTRATION SET | FPK | 1995-02-08 | 107 |
Recalls
openFDA lists no recalls under a recalling firm named Distronic Sterile Products, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Distronic Sterile Products, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Distronic Sterile Products, Inc.” (first 1995, latest 1996), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Distronic Sterile Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Distronic Sterile Products, Inc. is 74 days.
Which FDA product codes appear under Distronic Sterile Products, Inc.?
The most frequent FDA product codes under this applicant name are FPA (Set, Administration, Intravascular, 5); FPK (Tubing, Fluid Delivery, 2); FMG (Stopcock, I.V. Set, 1).
Next steps
- See all 8 Distronic Sterile Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FPA, Distronic Sterile Products, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.