Churchill Corp.: FDA filings under this applicant name
FDA lists 35 510(k) clearances under the applicant name “Churchill Corp.” (first 1985, latest 1988), across 15 product codes in 5 review panels. Median 510(k) review time under this name: 52 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 | 15 | 15 |
| FPB | Filter, Infusion Line | 3 | 3 |
| FPK | Tubing, Fluid Delivery | 3 | 3 |
| FMG | Stopcock, I.V. Set | 2 | 2 |
| FMI | Needle, Hypodermic, Single Lumen | 2 | 2 |
| BRZ | Set, Blood Transfusion | 1 | 1 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 1 | 1 |
| DZM | Needle, Dental | 1 | 1 |
| FMF | Syringe, Piston | 1 | 1 |
| FMK | Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | 1 | 1 |
Plus 5 more product codes.
Review panels
- General Hospital (31)
- Cardiovascular (1)
- Dental (1)
- Gastroenterology and Urology (1)
- General and Plastic Surgery (1)
Most recent Churchill Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K880051 | ENTERAL BAG/SET | KNT | 1988-04-14 | 99 |
| K880026 | CHURCHILL 0.22 MICRON LIQUID COMPACT FILTER SETS | FPB | 1988-04-14 | 100 |
| K880025 | CHURCHILL 0.22 MICRON LIQUID FILTER SETS | FPB | 1988-04-14 | 100 |
| K880027 | CHURCHILL 1.2 MICRON LIQUID FILTER SET | FPB | 1988-04-13 | 99 |
| K872585 | CHURCHILL-CATH | FOZ | 1987-10-15 | 106 |
| K870395 | CHURCHILL PARENTERAL NUTRITION BAG - EVA | KPE | 1987-10-15 | 258 |
| K872124 | CHURCHILL ALBUMIN IV ADMINISTRATION SET | FPA | 1987-10-13 | 134 |
| K872123 | CHURCHILL TPN ADMINISTRATION SET | FPA | 1987-10-09 | 130 |
| K872043 | CHURCHILL INTER-CARDIAC SUCKER | DWF | 1987-09-30 | 126 |
| K871084 | NITROGLYCERINE PUMP SET | FRN | 1987-07-16 | 120 |
25 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Churchill Corp..
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Churchill Corp. (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via FRN)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via FRN)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via FRN)
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 Medical Systems, Inc. (12 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Churchill Corp.?
FDA lists 35 510(k) clearances under the applicant name “Churchill Corp.” (first 1985, latest 1988), across 15 product codes in 5 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 Churchill Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Churchill Corp. is 52 days.
Which FDA product codes appear under Churchill Corp.?
The most frequent FDA product codes under this applicant name are FPA (Set, Administration, Intravascular, 15); FPB (Filter, Infusion Line, 3); FPK (Tubing, Fluid Delivery, 3).
Next steps
- See all 35 Churchill Corp. clearances with predicates and recalls
- Run predicate analysis for product code FPA, Churchill Corp.'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.