Akcess Medical Products, Inc.: FDA filings under this applicant name
FDA lists 36 510(k) clearances under the applicant name “Akcess Medical Products, Inc.” (first 1989, latest 1994), across 16 product codes in 3 review panels. Median 510(k) review time under this name: 78 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 |
|---|---|---|---|
| LFJ | Catheter, Subclavian | 12 | 12 |
| LFK | Catheter, Femoral | 4 | 4 |
| FIQ | Cannula, A-V Shunt | 3 | 3 |
| KOC | Accessories, Blood Circuit, Hemodialysis | 3 | 3 |
| DQY | Catheter, Percutaneous | 2 | 2 |
| FKN | Adaptor, Shunt | 2 | 2 |
| FIB | Protector, Transducer, Dialysis | 1 | 1 |
| FJG | Dialyzer, Parallel Flow | 1 | 1 |
| FJQ | Connector, Shunt | 1 | 1 |
| FJS | Catheter, Peritoneal, Long-Term Indwelling | 1 | 1 |
Plus 6 more product codes.
Review panels
Most recent Akcess Medical Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K926374 | SILICONE CATHETER REPAIR KITS | KOC | 1994-10-07 | 654 |
| K925819 | AKCESS0CATH KIT | LFJ | 1994-08-02 | 623 |
| K925818 | AKCESS-CATH | LFJ | 1994-04-05 | 504 |
| K930630 | RIGHT ATRIAL CATHETER | LJS | 1994-02-07 | 364 |
| K931120 | COAXIAL ACUTE CATHETER | LFJ | 1994-01-14 | 316 |
| K920634 | SPLITTABLE SHEATH INTRODUCER SET | LFJ | 1994-01-14 | 702 |
| K914936 | CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATH SET | LFK | 1992-04-23 | 171 |
| K920331 | RIGHT ATRIAL CATHETER KITS | DQY | 1992-04-22 | 90 |
| K914826 | AKCESS-CATH KIT | LFJ | 1992-04-10 | 168 |
| K915215 | CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATH. KITS | LFK | 1992-03-27 | 130 |
26 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Akcess Medical Products, 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 Akcess Medical Products, Inc.?
FDA lists 36 510(k) clearances under the applicant name “Akcess Medical Products, Inc.” (first 1989, latest 1994), across 16 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 Akcess Medical Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Akcess Medical Products, Inc. is 78 days.
Which FDA product codes appear under Akcess Medical Products, Inc.?
The most frequent FDA product codes under this applicant name are LFJ (Catheter, Subclavian, 12); LFK (Catheter, Femoral, 4); FIQ (Cannula, A-V Shunt, 3).
Next steps
- See all 36 Akcess Medical Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LFJ, Akcess Medical Products, 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.