Future Medical Systems, Inc.: FDA clearances and approvals
Future Medical Systems, Inc. has 12 FDA 510(k) clearances (first 1995, latest 2003), across 5 product codes in 3 review panels. Median 510(k) review time: 67 days.
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 |
|---|---|---|---|
| HRX | Arthroscope | 6 | 6 |
| HNX | Depressor, Orbital | 2 | 2 |
| HWC | Screw, Fixation, Bone | 2 | 2 |
| LJH | System, Irrigation, Urological | 1 | 1 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 1 | 1 |
Review panels
- Orthopedic (9)
- Ophthalmic (2)
- Gastroenterology and Urology (1)
Most recent Future Medical Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K023963 | ADHOC CLAW | MBI | 2003-05-05 | 157 |
| K021030 | TITANIUM CANNULATED INTERFERENCE SCREW | HWC | 2002-06-25 | 88 |
| K013685 | PLLA CANNULATED INTERFERENCE SCREW | HWC | 2002-01-18 | 72 |
| K002040 | FMS SOLO | HRX | 2000-09-11 | 68 |
| K980808 | ENDO FMS UROLOGY | LJH | 1998-05-08 | 66 |
| K955500 | FMS ARTHOPROBE | HRX | 1996-02-05 | 66 |
| K954465 | FMS DUO | HRX | 1995-11-09 | 45 |
| K954217 | ARTHROPLAST & ARTHRO-CUTTER | HRX | 1995-10-23 | 45 |
| K951843 | REF. 4102CV INTERMEDIARY TUBING, REF. 4509CV STERILE ZONE KIT | HRX | 1995-07-14 | 85 |
| K951702 | FMS HIGH FLOW ARTHRO-SHEATH | HNX | 1995-05-12 | 30 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Future Medical Systems, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Future Medical Systems, Inc. have?
Future Medical Systems, Inc. has 12 FDA 510(k) clearances (first 1995, latest 2003), across 5 product codes in 3 review panels.
How long does FDA take to clear Future Medical Systems, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Future Medical Systems, Inc.'s cleared 510(k)s is 67 days.
What devices does Future Medical Systems, Inc. make?
Its most frequent FDA product codes are HRX (Arthroscope, 6); HNX (Depressor, Orbital, 2); HWC (Screw, Fixation, Bone, 2).
Has Future Medical Systems, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Future Medical Systems, Inc. Related entities may recall under other names.
Next steps
- See all 12 Future Medical Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HRX, Future Medical Systems, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.