Faulding Medical Device Co.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Faulding Medical Device Co.” (first 1996, latest 1997), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 64 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 | 4 | 4 |
| LHI | Set, I.V. Fluid Transfer | 1 | 1 |
| MRZ | Accessories, Pump, Infusion | 1 | 1 |
Review panels
- General Hospital (6)
Most recent Faulding Medical Device Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K962159 | STERILE AMBULATORY RESERVOIR 60ML/100ML | MRZ | 1997-07-18 | 409 |
| K970909 | SAFE-CONNECT I.V. SET | FPA | 1997-05-06 | 55 |
| K971266 | SAFE-CONNECT Y-SITE ADAPTER CATALOG NO. 681518 | FPA | 1997-05-01 | 27 |
| K970789 | SAFE-CONNECT VIAL DISPENSING SPIKE | LHI | 1997-05-01 | 58 |
| K970524 | SAFE-CONNECT I.V. EXTENSION SET | FPA | 1997-04-22 | 70 |
| K955775 | SAFECONNECT VALVE (CATALOG NO. XXXX) | FPA | 1996-11-15 | 330 |
Recalls
openFDA lists no recalls under a recalling firm named Faulding Medical Device Co..
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 Faulding Medical Device Co. (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via MRZ)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via MRZ)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via MRZ)
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.
- Faulding Pharmaceutical Co. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Faulding Medical Device Co.?
FDA lists 6 510(k) clearances under the applicant name “Faulding Medical Device Co.” (first 1996, latest 1997), across 3 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 Faulding Medical Device Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Faulding Medical Device Co. is 64 days.
Which FDA product codes appear under Faulding Medical Device Co.?
The most frequent FDA product codes under this applicant name are FPA (Set, Administration, Intravascular, 4); LHI (Set, I.V. Fluid Transfer, 1); MRZ (Accessories, Pump, Infusion, 1).
Next steps
- See all 6 Faulding Medical Device Co. clearances with predicates and recalls
- Run predicate analysis for product code FPA, Faulding Medical Device Co.'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.