Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
Narco Bio-Systems — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
35 daysmedian FDA review time
202 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K853683 | UMS-100 | Narco Bio-Systems | 1986-01-10 | 128 | 0 |
| K833656 | NARCOTRACE 40 - NT40 | Narco Bio-Systems | 1984-05-09 | 202 | 0 |
| K832869 | MOTILITY MEASUREMENT SYS MMS-100 | Narco Bio-Systems | 1983-10-31 | 68 | 0 |
| K813502 | NARCO TELECARE ISOFLO PRESSURE MONITOR | Narco Bio-Systems | 1981-12-29 | 14 | 0 |
| K811376 | ULTRASONIC QFM SYSTEM 1000 | Narco Bio-Systems | 1981-08-13 | 90 | 0 |
| K810431 | NARCO TLECARE MINIATURE PRESSURE DOME | Narco Bio-Systems | 1981-03-11 | 20 | 0 |
| K801544 | PORTA-FIB LPD | Narco Bio-Systems | 1980-07-14 | 7 | 0 |
| K760084 | MONITOR, GSR (NB-401) | Narco Bio-Systems | 1976-07-26 | 35 | 0 |
| K760083 | PHYSIOSCOPE | Narco Bio-Systems | 1976-07-20 | 29 | 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