Sterile Design, Inc.: FDA clearances and approvals
Sterile Design, Inc. has 10 FDA 510(k) clearances (first 1979, latest 1994), across 9 product codes in 3 review panels. Median 510(k) review time: 148 days.
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 |
|---|---|---|---|
| DQX | Wire, Guide, Catheter | 1 | 1 |
| DRS | Transducer, Blood-Pressure, Extravascular | 1 | 1 |
| DWE | Tubing, Pump, Cardiopulmonary Bypass | 1 | 1 |
| FMC | Patient Examination Glove | 1 | 1 |
| FPA | Set, Administration, Intravascular | 1 | 1 |
| FRG | Wrap, Sterilization | 1 | 1 |
| JOD | Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass | 1 | 1 |
| LRO | General Surgery Tray | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Sterile Design, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K934688 | STERILE DESIGN | LRO | 1994-03-16 | 167 |
| K841960 | CARDIO METRICS INVASIVE PRESSURE MONIT | DRS | 1985-11-08 | 543 |
| K842356 | CUSTOM STERILE PROCEDURE KITS | — | 1985-03-21 | 279 |
| K841959 | CARDIO METRIC CUSTOM PERFUSION TUBING | DWE | 1984-10-19 | 158 |
| K842351 | STERILE DESIGN-CUSTOM STERILE IV KIT | FPA | 1984-10-15 | 122 |
| K841958 | CARDIO METRICS CARDIOTOMY RESERVOIR | JOD | 1984-10-15 | 154 |
| K834239 | SDI C-FLEX STERILE LIGHT HANDLE | — | 1984-04-25 | 141 |
| K834237 | GRADUATED GUIDE WIRE BOWL 8 | DQX | 1984-02-04 | 60 |
| K813437 | PAN SET | FRG | 1981-12-31 | 23 |
| K791738 | CUSTOM DRESSING CHANGE TRAYS | FMC | 1979-10-02 | 33 |
Recalls
openFDA lists no recalls under a recalling firm named Sterile Design, 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 Sterile Design, Inc. have?
Sterile Design, Inc. has 10 FDA 510(k) clearances (first 1979, latest 1994), across 9 product codes in 3 review panels.
How long does FDA take to clear Sterile Design, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Sterile Design, Inc.'s cleared 510(k)s is 148 days.
What devices does Sterile Design, Inc. make?
Its most frequent FDA product codes are DQX (Wire, Guide, Catheter, 1); DRS (Transducer, Blood-Pressure, Extravascular, 1); DWE (Tubing, Pump, Cardiopulmonary Bypass, 1).
Has Sterile Design, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Sterile Design, Inc. Related entities may recall under other names.
Next steps
- See all 10 Sterile Design, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DQX, Sterile Design, 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.