Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Med Fusion Systems, Inc. · Predicate Candidate Screening
22 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
48 daysmedian FDA review time
95 days90th percentile
22clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K873961 | INFUMED 300 AMBULATORY INFUSION PUMP | Med Fusion Systems, Inc. | 1987-12-29 | 91 | 0 |
| K870524 | AMBULATORY INFUSION PUMP DRUG RESERVOIR | Med Fusion Systems, Inc. | 1987-05-06 | 89 | 0 |
| K870907 | INTRODUCER, PERCUTANEOUS | Med Fusion Systems, Inc. | 1987-04-09 | 35 | 0 |
| K864407 | REFILLABLE SYRINGE | Med Fusion Systems, Inc. | 1987-01-20 | 71 | 0 |
| K863814 | BAG SPIKE EXTENSION SET | Med Fusion Systems, Inc. | 1986-10-14 | 14 | 0 |
| K860616 | VOLUME CONTROL SET WITH EXTENSION | Med Fusion Systems, Inc. | 1986-06-02 | 103 | 0 |
| K860803 | IV FILTER EXTENSION SET | Med Fusion Systems, Inc. | 1986-04-09 | 36 | 0 |
| K844313 | INFUSET W/HUBER NEEDLE | Med Fusion Systems, Inc. | 1985-01-22 | 77 | 0 |
| K842984 | EXTENSION SET W/INJECTION SITE | Med Fusion Systems, Inc. | 1984-10-16 | 78 | 0 |
| K842143 | BENT WINGED MINI-VOL INFUSION SET | Med Fusion Systems, Inc. | 1984-07-20 | 51 | 0 |
| K841882 | THREE WAY INFUSION SET | Med Fusion Systems, Inc. | 1984-06-05 | 29 | 0 |
| K772276 | RAISED TOILET SEAT | Med Fusion Systems, Inc. | 1978-03-14 | 95 | 0 |
| K772275 | TOILET SAFETY RAIL | Med Fusion Systems, Inc. | 1978-03-14 | 95 | 0 |
| K772261 | TRAPEZE FLOOR BASE | Med Fusion Systems, Inc. | 1978-01-26 | 48 | 0 |
| K772262 | TRAPEZE BAR KNOCKED DOWN | Med Fusion Systems, Inc. | 1978-01-26 | 48 | 0 |
| K772260 | TELESCOPING BEDRAILS | Med Fusion Systems, Inc. | 1978-01-26 | 48 | 0 |
| K772266 | INSTRUMENT TRAY | Med Fusion Systems, Inc. | 1978-01-20 | 42 | 0 |
| K772268 | DEMI-WALKER (REGULAR) | Med Fusion Systems, Inc. | 1977-12-20 | 11 | 0 |
| K772267 | QUADRAPLEGIC WALKING AID | Med Fusion Systems, Inc. | 1977-12-20 | 11 | 0 |
| K772270 | SETUP WALKER OVER TOILET CONSTRUC. | Med Fusion Systems, Inc. | 1977-12-20 | 11 | 0 |
| K772269 | SETUP WALKER ADJUSTABLE | Med Fusion Systems, Inc. | 1977-12-20 | 11 | 0 |
| K772271 | WALKER FOLDING ADJUSTABLE | Med Fusion Systems, Inc. | 1977-12-20 | 11 | 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