Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Advantage Medical Systems, Inc. · Predicate Candidate Screening
17 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
48 daysmedian FDA review time
117 days90th percentile
17clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K873957 | NON-CORING HUBER TYPE NEEDLES | Advantage Medical Systems, Inc. | 1987-10-23 | 25 | 1 |
| K873290 | LACERATION AND INSTRUMENT TRAYS | Advantage Medical Systems, Inc. | 1987-09-24 | 38 | 0 |
| K863494 | NEONATAL PHYSIOLOGICAL MONITOR MODEL PM 20 | Advantage Medical Systems, Inc. | 1986-12-22 | 104 | 0 |
| K861556 | MODIFIED FETAL MONITOR MODEL FM-2 | Advantage Medical Systems, Inc. | 1986-07-07 | 73 | 0 |
| K861279 | FLUORO PLUS | Advantage Medical Systems, Inc. | 1986-06-16 | 70 | 0 |
| K861455 | MODEL DT-102 DATA TELEPHONE TRANSMITTER | Advantage Medical Systems, Inc. | 1986-05-30 | 42 | 0 |
| K852518 | MODIFICATION FETAL MONITOR MODEL FM-2 | Advantage Medical Systems, Inc. | 1985-07-05 | 23 | 0 |
| K844724 | FETAL TELEMETRY SYSTEM | Advantage Medical Systems, Inc. | 1985-05-01 | 148 | 0 |
| K842462 | HOLTER SCREENING MONITOR HS-221 | Advantage Medical Systems, Inc. | 1984-09-11 | 81 | 0 |
| K840747 | TOCO DATA TELEPHONE TRANSMITTER DT100P | Advantage Medical Systems, Inc. | 1984-06-19 | 117 | 0 |
| K832849 | FETAL MONITOR #FM-2 | Advantage Medical Systems, Inc. | 1983-10-04 | 43 | 0 |
| K822626 | ATC BIOELECTROGRAPHIC MONITOR MODEL I. | Advantage Medical Systems, Inc. | 1982-09-15 | 13 | 0 |
| K821478 | TELEPHONE LINK DATA TRANSMISSION SYS | Advantage Medical Systems, Inc. | 1982-07-26 | 69 | 0 |
| K821580 | FETAL MONITOR #FM 750 | Advantage Medical Systems, Inc. | 1982-06-25 | 31 | 0 |
| K821479 | CENTRAL DISPLAY SYSTEM #CS400 | Advantage Medical Systems, Inc. | 1982-06-25 | 38 | 0 |
| K801541 | WALL MOUNTED LASER POSITIONING DEVICE | Advantage Medical Systems, Inc. | 1980-08-20 | 48 | 0 |
| K800013 | FETAL MONITOR MODEL FHM-1 | Advantage Medical Systems, Inc. | 1980-03-07 | 63 | 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