Getinge Sourcing, LLC: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Getinge Sourcing, LLC” (first 2007, latest 2016), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 166 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Getinge, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 108 |
| 2013 | 3 | 267 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 166 |
| 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 | 5 | 5 |
| LHC | Warmer, Irrigation Solution | 1 | 1 |
| PEC | Sterilizer Automated Loading System | 1 | 1 |
Review panels
- General Hospital (7)
Most recent Getinge Sourcing, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K153713 | Getinge Series Warming Cabinet | LHC | 2016-06-07 | 166 |
| K122625 | GETINGE 800HC- SERIES STEAM STERILIZER | FLE | 2013-05-22 | 267 |
| K120532 | GETINGE 633HC STEAM STERILIZER AIR GLIDE SYSTEM | PEC | 2013-05-02 | 435 |
| K122071 | GETINGE 400HC-E / SERIES STEAM STERILIZER | FLE | 2013-03-12 | 239 |
| K120441 | GETINGE 700HC-E SERIES STEAM STERILIZER | FLE | 2012-05-31 | 108 |
| K103504 | GETINGE 400HC/500HC SERIES STEAM STERILIZER | FLE | 2011-03-16 | 110 |
| K070657 | GETINGE 633HC SERIES VACUUM/GRAVITY STEAM STERILIZER | FLE | 2007-04-05 | 27 |
Recalls
openFDA lists no recalls under a recalling firm named Getinge Sourcing, LLC.
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Getinge/Castle, Inc. (9 510(k)s)
- Getinge International, Inc. (4 510(k)s)
- Getinge USA, Inc. (4 510(k)s)
- Getinge (Suzhou) Co., Ltd. (2 510(k)s)
- Getinge Disinfection, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Getinge Sourcing, LLC?
FDA lists 7 510(k) clearances under the applicant name “Getinge Sourcing, LLC” (first 2007, latest 2016), 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 Getinge Sourcing, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Getinge Sourcing, LLC is 166 days.
Which FDA product codes appear under Getinge Sourcing, LLC?
The most frequent FDA product codes under this applicant name are FLE (Sterilizer, Steam, 5); LHC (Warmer, Irrigation Solution, 1); PEC (Sterilizer Automated Loading System, 1).
Next steps
- See all 7 Getinge Sourcing, LLC clearances with predicates and recalls
- Run predicate analysis for product code FLE, Getinge Sourcing, LLC'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.