Med Fusion Systems, Inc.: FDA filings under this applicant name
FDA lists 22 510(k) clearances under the applicant name “Med Fusion Systems, Inc.” (first 1977, latest 1987), across 11 product codes in 4 review panels. Median 510(k) review time under this name: 48 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 | 5 | 5 |
| ITQ | Joint, Knee, External Brace | 4 | 4 |
| FNJ | Bed, Manual | 3 | 3 |
| FRN | Pump, Infusion | 2 | 2 |
| LDQ | 2 | 2 | |
| DYB | Introducer, Catheter | 1 | 1 |
| FMF | Syringe, Piston | 1 | 1 |
| FMI | Needle, Hypodermic, Single Lumen | 1 | 1 |
| FPB | Filter, Infusion Line | 1 | 1 |
| FSM | Tray, Surgical, Instrument | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Med Fusion Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K873961 | INFUMED 300 AMBULATORY INFUSION PUMP | FRN | 1987-12-29 | 91 |
| K870524 | AMBULATORY INFUSION PUMP DRUG RESERVOIR | FRN | 1987-05-06 | 89 |
| K870907 | INTRODUCER, PERCUTANEOUS | DYB | 1987-04-09 | 35 |
| K864407 | REFILLABLE SYRINGE | FMF | 1987-01-20 | 71 |
| K863814 | BAG SPIKE EXTENSION SET | FPA | 1986-10-14 | 14 |
| K860616 | VOLUME CONTROL SET WITH EXTENSION | FPA | 1986-06-02 | 103 |
| K860803 | IV FILTER EXTENSION SET | FPB | 1986-04-09 | 36 |
| K844313 | INFUSET W/HUBER NEEDLE | FMI | 1985-01-22 | 77 |
| K842984 | EXTENSION SET W/INJECTION SITE | FPA | 1984-10-16 | 78 |
| K842143 | BENT WINGED MINI-VOL INFUSION SET | FPA | 1984-07-20 | 51 |
12 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Med Fusion Systems, 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 Med Fusion Systems, Inc. (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)
Frequently asked questions
How many FDA 510(k) clearances are listed under Med Fusion Systems, Inc.?
FDA lists 22 510(k) clearances under the applicant name “Med Fusion Systems, Inc.” (first 1977, latest 1987), across 11 product codes in 4 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 Med Fusion Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Med Fusion Systems, Inc. is 48 days.
Which FDA product codes appear under Med Fusion Systems, Inc.?
The most frequent FDA product codes under this applicant name are FPA (Set, Administration, Intravascular, 5); ITQ (Joint, Knee, External Brace, 4); FNJ (Bed, Manual, 3).
Next steps
- See all 22 Med Fusion Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FPA, Med Fusion Systems, 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.