Sigma Medical, Inc.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Sigma Medical, Inc.” (first 1985, latest 1985), across 1 product code in 1 review panel. Median 510(k) review time under this name: 46 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 |
|---|---|---|---|
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) | 13 | 13 |
Review panels
- Anesthesiology (13)
Most recent Sigma Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K853065 | #6003 NON CONDUCTIVE ANESTHESIA CIR W/ BREATH BAG | CAI | 1985-09-03 | 46 |
| K853344 | 4000 NON CONDUCTIVE ANESTHESIA VENTILATOR CIRCUIT | CAI | 1985-08-29 | 22 |
| K853343 | 3015 PEDIATRIC NON-CONDUCTIVE ANESTHESIA CIRCUIT W | CAI | 1985-08-29 | 22 |
| K853342 | 6013 NON CONDUCTIVE ANESTHESIA CIRCUIT W/BREATHBAG | CAI | 1985-08-29 | 22 |
| K852314 | #6010 NON-CONDUCTIVE VENTILATOR CIRCUIT | CAI | 1985-08-13 | 76 |
| K852316 | #3011 PEDIATRIC NON-CONDUCT ANES CIR W/ BREA BAG | CAI | 1985-07-15 | 47 |
| K852315 | #3012 PEDIATRIC NON-CONDUCT ANES CIR W/ BREA BAG | CAI | 1985-07-15 | 47 |
| K852313 | #3001 PEDIATRIC NON-CONDUCT ANES CIR W/ BREA BAG | CAI | 1985-07-15 | 47 |
| K852312 | #3005 PEDIATRIC NON-CONDUCT ANES CIR W/ BREA BAG | CAI | 1985-07-15 | 47 |
| K852311 | #3002 PEDIATRIC NON-CONDUCT ANES CIR W/ BREA BAG | CAI | 1985-07-15 | 47 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Sigma Medical, 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.
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.
- Sigma Chemical Co. (231 510(k)s)
- Sigma Diagnostics, Inc. (164 510(k)s)
- Sigma (6 510(k)s)
- Sigma Medical Supplies Corp. (5 510(k)s)
- Sigma Intl. (3 510(k)s)
- Sigma Cell Culture Reagents (2 510(k)s)
- Sigma Biomedical (1 510(k)s)
- Sigma Biomedics, Inc. (1 510(k)s)
- Sigma Distribution & Supply, Inc. (1 510(k)s)
- Sigma Intl. General Medical Apparatus, Inc. (1 510(k)s)
- Sigma Scientific Services, LLC (1 510(k)s)
- Sigma Teleproducts, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Sigma Medical, Inc.?
FDA lists 13 510(k) clearances under the applicant name “Sigma Medical, Inc.” (first 1985, latest 1985), across 1 product code 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 Sigma Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sigma Medical, Inc. is 46 days.
Which FDA product codes appear under Sigma Medical, Inc.?
The most frequent FDA product codes under this applicant name are CAI (Circuit, Breathing (W Connector, Adaptor, Y Piece), 13).
Next steps
- See all 13 Sigma Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CAI, Sigma Medical, 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.