Cunningham Woodland, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Cunningham Woodland, Inc.” (first 1981, latest 1983), across 7 product codes in 3 review panels. Median 510(k) review time under this name: 17 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 |
|---|---|---|---|
| LDQ | 4 | 4 | |
| DWS | Instruments, Surgical, Cardiovascular | 1 | 1 |
| FMF | Syringe, Piston | 1 | 1 |
| FSM | Tray, Surgical, Instrument | 1 | 1 |
| GDY | Gauze/Sponge, Internal, X-Ray Detectable | 1 | 1 |
| KDD | Kit, Surgical Instrument, Disposable | 1 | 1 |
| KME | Bedding, Disposable, Medical | 1 | 1 |
Review panels
Most recent Cunningham Woodland, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K823527 | SUBCLAVIAN INSERTION KIT | FMF | 1983-03-31 | 121 |
| K813286 | PRE-PACK TENS | GDY | 1982-01-22 | 60 |
| K813519 | NON-ABSORBENT TOWELS | KME | 1982-01-05 | 20 |
| K813284 | VENOUS CANNULA TRAY | DWS | 1981-12-29 | 36 |
| K811091 | MINOR DRESSING TRAY | LDQ | 1981-05-08 | 17 |
| K811090 | MAJOR DRESSING TRAY | LDQ | 1981-05-08 | 17 |
| K811089 | ONE STEP PREP KIT | LDQ | 1981-05-08 | 17 |
| K811088 | DRESSING TRAY MERCY HOSPITAL | LDQ | 1981-05-08 | 17 |
| K811087 | MIKA SKIN SCRUB TRAY PRE OPERATIVE W/GEL | FSM | 1981-05-01 | 10 |
| K811086 | SUTURE REMOVAL SET(DISPLSABLE) | KDD | 1981-05-01 | 10 |
Recalls
openFDA lists no recalls under a recalling firm named Cunningham Woodland, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Cunningham Woodland, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Cunningham Woodland, Inc.” (first 1981, latest 1983), across 7 product codes in 3 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 Cunningham Woodland, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cunningham Woodland, Inc. is 17 days.
Which FDA product codes appear under Cunningham Woodland, Inc.?
The most frequent FDA product codes under this applicant name are LDQ (device, 4); DWS (Instruments, Surgical, Cardiovascular, 1); FMF (Syringe, Piston, 1).
Next steps
- See all 10 Cunningham Woodland, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LDQ, Cunningham Woodland, 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.