Vlv Associates, Inc.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Vlv Associates, Inc.” (first 1986, latest 1997), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 89 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 | 8 | 8 |
| DWO | Needle, Biopsy, Cardiovascular | 1 | 1 |
| FMF | Syringe, Piston | 1 | 1 |
| KMK | Device, Intravascular Catheter Securement | 1 | 1 |
| MEB | Pump, Infusion, Elastomeric | 1 | 1 |
Review panels
Most recent Vlv Associates, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K972957 | SA-EF MULTI-LUMEN EXTENSION SET | FPA | 1997-09-29 | 49 |
| K964876 | SA.EF(TM) INFUSION PORT II - CONNECTOR AND EXTENSION SET | FPA | 1997-02-28 | 85 |
| K955783 | VLV SA.EF INFUSION PORT EXTENSION SETS | FPA | 1996-02-07 | 48 |
| K953791 | VLV SA EF INFUSION PORT | FPA | 1995-10-30 | 77 |
| K945592 | VLV SOLODRAW(TM) DUAL CHAMBER PISTON SYRINGE | FMF | 1995-07-14 | 242 |
| K940406 | DISPOSABLE, AMBULATORY, INFUSION PUMPS | MEB | 1994-09-02 | 218 |
| K933364 | PROMED BIOPSY NEEDLE | DWO | 1994-02-15 | 221 |
| K922469 | PRO-LOK EXTENSION SET(S) | FPA | 1993-03-15 | 293 |
| K904217 | PRO-LOK (TM) EXTENSION SETS | FPA | 1990-10-03 | 21 |
| K901081 | PRO-LOCK(TM) SHIELDING NEEDLE CONNECTOR ASSEMBLY | FPA | 1990-06-08 | 93 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Vlv Associates, 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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Vlv Associates, Inc. (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via MEB)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via MEB)
Frequently asked questions
How many FDA 510(k) clearances are listed under Vlv Associates, Inc.?
FDA lists 12 510(k) clearances under the applicant name “Vlv Associates, Inc.” (first 1986, latest 1997), across 5 product codes in 2 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 Vlv Associates, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Vlv Associates, Inc. is 89 days.
Which FDA product codes appear under Vlv Associates, Inc.?
The most frequent FDA product codes under this applicant name are FPA (Set, Administration, Intravascular, 8); DWO (Needle, Biopsy, Cardiovascular, 1); FMF (Syringe, Piston, 1).
Next steps
- See all 12 Vlv Associates, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FPA, Vlv Associates, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.