Getinge/Castle, Inc.: FDA clearances and approvals
Getinge/Castle, Inc. has 9 FDA 510(k) clearances (first 1997, latest 2002), across 3 product codes in 2 review panels. Median 510(k) review time: 57 days. openFDA lists 1 product recall by a recalling firm named Getinge/Castle, Inc.
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 |
|---|---|---|---|
| FLE | Sterilizer, Steam | 6 | 6 |
| FSY | Light, Surgical, Ceiling Mounted | 2 | 2 |
| FRC | Indicator, Biological Sterilization Process | 1 | 1 |
Review panels
Most recent Getinge/Castle, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K020205 | CASTLE PERACETIC ACID BIOLOGICAL INDICATOR KIT | FRC | 2002-06-24 | 153 |
| K020590 | MODEL 733HC GRAVITY/VACUUM STEAM STERILIZER | FLE | 2002-03-20 | 26 |
| K012573 | CASTLE 400HC/500HC SERIES STEAM STERILIZER, MODELS 422HC, 433HC, 522HC, AND 533HC | FLE | 2001-09-05 | 27 |
| K003441 | CASTLE MODEL 233HC STEAM STERILIZER | FLE | 2001-01-02 | 57 |
| K994314 | CASTLE SERIES 100HC STEAM STERILIZERS | FLE | 2000-02-16 | 56 |
| K993242 | CASTLE SURGICAL LIGHT, MODEL 3000 | FSY | 1999-11-08 | 42 |
| K974084 | GETINGE/CASTLE OPTIVIEW SERIES SURGICAL LIGHT | FSY | 1998-03-03 | 125 |
| K973225 | CASTLE SERIES 200 STEAM STERILIZER (POWERCLAVE) | FLE | 1998-02-10 | 167 |
| K970907 | CASTLE SERIES 100 STEAM STERILIZERS (STRAIGHTLINE) | FLE | 1997-11-12 | 246 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2003-03-25.
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 Getinge/Castle, Inc. have?
Getinge/Castle, Inc. has 9 FDA 510(k) clearances (first 1997, latest 2002), across 3 product codes in 2 review panels.
How long does FDA take to clear Getinge/Castle, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Getinge/Castle, Inc.'s cleared 510(k)s is 57 days.
What devices does Getinge/Castle, Inc. make?
Its most frequent FDA product codes are FLE (Sterilizer, Steam, 6); FSY (Light, Surgical, Ceiling Mounted, 2); FRC (Indicator, Biological Sterilization Process, 1).
Has Getinge/Castle, Inc. had device recalls?
openFDA lists 1 product recall in 1 recall event by a recalling firm whose name matches Getinge/Castle, Inc; the most recent began 2003-03-25. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 9 Getinge/Castle, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FLE, Getinge/Castle, 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.