Sarstedt, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Sarstedt, Inc.” (first 1992, latest 2005), across 6 product codes in 4 review panels. Median 510(k) review time under this name: 124 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 |
|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | 1 | 1 |
| FPA | Set, Administration, Intravascular | 1 | 1 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | 1 | 1 |
| JSM | Culture Media, Non-Propagating Transport | 1 | 1 |
| KHE | Reagent, Occult Blood | 1 | 1 |
| PJE | Blood/Plasma Collection Device For Dna Testing | 1 | 1 |
Review panels
- Clinical Chemistry (2)
- General Hospital (2)
- Hematology (1)
- Microbiology (1)
Most recent Sarstedt, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K051019 | SAFETY NEEDLE | JKA | 2005-07-25 | 94 |
| K032150 | SAFETY-MULTIFLY | FPA | 2003-09-12 | 60 |
| K031359 | S-MONOVETTE EDTA K2-GEL | PJE | 2003-09-12 | 135 |
| K024237 | URINE MONOVETTE BORIC ACID | JSM | 2003-04-14 | 112 |
| K003382 | SARSTEDT NEEDLE PROTECTOR | FMI | 2001-03-30 | 150 |
| K913622 | HEMOPLUS | KHE | 1992-01-31 | 170 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2008-08-27.
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.
- Sarstedt AG & CO KG (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Sarstedt, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Sarstedt, Inc.” (first 1992, latest 2005), across 6 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Sarstedt, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sarstedt, Inc. is 124 days.
Which FDA product codes appear under Sarstedt, Inc.?
The most frequent FDA product codes under this applicant name are FMI (Needle, Hypodermic, Single Lumen, 1); FPA (Set, Administration, Intravascular, 1); JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection, 1).
Next steps
- See all 6 Sarstedt, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FMI, Sarstedt, 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.