Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Future Medical Systems, Inc. · Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
68 daysmedian FDA review time
104 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K023963 | ADHOC CLAW | Future Medical Systems, Inc. | 2003-05-05 | 157 | 0 |
| K021030 | TITANIUM CANNULATED INTERFERENCE SCREW | Future Medical Systems, Inc. | 2002-06-25 | 88 | 0 |
| K013685 | PLLA CANNULATED INTERFERENCE SCREW | Future Medical Systems, Inc. | 2002-01-18 | 72 | 0 |
| K002040 | FMS SOLO | Future Medical Systems, Inc. | 2000-09-11 | 68 | 1 |
| K980808 | ENDO FMS UROLOGY | Future Medical Systems, Inc. | 1998-05-08 | 66 | 0 |
| K955500 | FMS ARTHOPROBE | Future Medical Systems, Inc. | 1996-02-05 | 66 | 0 |
| K954465 | FMS DUO | Future Medical Systems, Inc. | 1995-11-09 | 45 | 2 |
| K954217 | ARTHROPLAST & ARTHRO-CUTTER | Future Medical Systems, Inc. | 1995-10-23 | 45 | 0 |
| K951843 | REF. 4102CV INTERMEDIARY TUBING, REF. 4509CV STERILE ZONE KI | Future Medical Systems, Inc. | 1995-07-14 | 85 | 3 |
| K951702 | FMS HIGH FLOW ARTHRO-SHEATH | Future Medical Systems, Inc. | 1995-05-12 | 30 | 0 |
| K951701 | FMS ARTHRO-CUTTER | Future Medical Systems, Inc. | 1995-05-09 | 27 | 0 |
| K945973 | FMS ARTHROSCOPY CANNULA | Future Medical Systems, Inc. | 1995-03-22 | 104 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda