Churchill Medical Systems, Inc.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Churchill Medical Systems, Inc.” (first 1988, latest 2004), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 66 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 |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | 7 | 7 |
| FPB | Filter, Infusion Line | 2 | 2 |
| FMG | Stopcock, I.V. Set | 1 | 1 |
| FPK | Tubing, Fluid Delivery | 1 | 1 |
| KPE | Container, I.V. | 1 | 1 |
Review panels
- General Hospital (12)
Most recent Churchill Medical Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K041038 | CHURCHILL MEDICAL DUAL CHAMBER EMPTY CONTAINER | KPE | 2004-12-21 | 243 |
| K021395 | MODIFICATION TO 30 EXTENSION SET | FPA | 2002-05-13 | 11 |
| K013949 | UNIVERSAL VIAL ACCESS SPIKE WITH NEEDLELESS CONNECTOR | FPA | 2002-03-27 | 117 |
| K020544 | WING SAFE INFUSION SET 20 GA, SHS2000 SERIES; WING SAFE INFUSION SET 19 GA, SHS1900 SERIES; WING SAFE INFUSION SET 22 GA | FPA | 2002-03-12 | 25 |
| K013950 | VENTED VIAL ACCESS DEVICE | FPA | 2002-01-10 | 41 |
| K012157 | CHURCHILL MEDICAL SYSTEMS STOPCOCK | FMG | 2001-09-11 | 62 |
| K011888 | PRESSURE ACTIVATED CHECK VALVE | FPA | 2001-09-10 | 84 |
| K011336 | PRIMARY SOLUTION SET WITH UNIVERSAL SPIKE, INJECTION SITE AND MALE LUER LOCK | FPA | 2001-06-12 | 41 |
| K896333 | CMS IV FILTERS | FPB | 1990-01-11 | 69 |
| K894954 | .22 & 1.2 MICRON IV FILTERS | FPB | 1989-11-13 | 101 |
2 earlier clearances. See the full list in Caduvo.
Recalls
36 product recalls in 9 recall events; 0 initiated in the last five years. Most recent: 2015-01-15.
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.
- Churchill Corp. (35 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Churchill Medical Systems, Inc.?
FDA lists 12 510(k) clearances under the applicant name “Churchill Medical Systems, Inc.” (first 1988, latest 2004), across 5 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 Churchill Medical Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Churchill Medical Systems, Inc. is 66 days.
Which FDA product codes appear under Churchill Medical Systems, Inc.?
The most frequent FDA product codes under this applicant name are FPA (Set, Administration, Intravascular, 7); FPB (Filter, Infusion Line, 2); FMG (Stopcock, I.V. Set, 1).
Next steps
- See all 12 Churchill Medical Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FPA, Churchill Medical Systems, 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.