Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Novametrix Medical Systems, Inc. · Predicate Candidate Screening
45 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
69 daysmedian FDA review time
148 days90th percentile
45clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K010451 | NOVAMETRIX MARQUETTE COMPATIBLE SENSORS | Novametrix Medical Systems, Inc. | 2001-04-25 | 69 | 0 |
| K000794 | MODIFICATION TO MARSPO2, MODEL 2001 | Novametrix Medical Systems, Inc. | 2000-04-10 | 28 | 5 |
| K993979 | MARSPO2, MODEL 2001 | Novametrix Medical Systems, Inc. | 2000-02-22 | 90 | 1 |
| K982499 | COSMO PLUS WITH NICO, MODEL 8200 | Novametrix Medical Systems, Inc. | 1998-10-16 | 88 | 1 |
| K964360 | VENT(VENTCHECK) HANDHELD RESPIRATORY/MECHANICS MONITOR MODEL | Novametrix Medical Systems, Inc. | 1997-04-04 | 154 | 0 |
| K963380 | CO 2 SMO PLUS | Novametrix Medical Systems, Inc. | 1997-01-22 | 148 | 3 |
| K963327 | TIDAL WAVE CARBON DIOXIDE MONITOR, MODEL 610 | Novametrix Medical Systems, Inc. | 1996-11-20 | 89 | 4 |
| K960831 | VENTRAK RMMS 1550 | Novametrix Medical Systems, Inc. | 1996-05-29 | 90 | 0 |
| K924626 | NOVAMETRIX MODEL 510 | Novametrix Medical Systems, Inc. | 1993-12-03 | 445 | 0 |
| K920379 | NOVAMETRIX MODEL 7100 COMB. END TIDAL CO2 & PUL OX | Novametrix Medical Systems, Inc. | 1992-07-15 | 168 | 3 |
| K913516 | MODEL 520A NOVAMETRIX PULSE OXIMETER | Novametrix Medical Systems, Inc. | 1991-11-04 | 89 | 5 |
| K910019 | NOVAMETRIX MODEL 1265 END TIDAL CARBON DIOXIDE MON | Novametrix Medical Systems, Inc. | 1991-03-26 | 82 | 3 |
| K893643 | NOVAMETRIX MDLS 500A, 505A, 515A, & 7000A OXIMETER | Novametrix Medical Systems, Inc. | 1989-10-26 | 164 | 6 |
| K890517 | TRANSCUTANEOUS O2/CO2 MONITOR | Novametrix Medical Systems, Inc. | 1989-04-14 | 74 | 4 |
| K873672 | MODEL 1010 PHYSIOLOGICAL SIGNAL TELEMETRY MONITOR | Novametrix Medical Systems, Inc. | 1987-12-03 | 83 | 0 |
| K874036 | MODEL 7000 COMBINATION END TIDAL & PULSE OXIMETRY | Novametrix Medical Systems, Inc. | 1987-11-06 | 32 | 0 |
| K873149 | NOVAMETRIX END TIDAL CO2 MONITOR, MODEL 1260 | Novametrix Medical Systems, Inc. | 1987-11-06 | 87 | 0 |
| K873078 | NOVAMETRIX MODEL 505 PULSE OXIMETER | Novametrix Medical Systems, Inc. | 1987-09-23 | 49 | 0 |
| K871338 | NOVAMETRIX MODEL 200 MAGSTIM | Novametrix Medical Systems, Inc. | 1987-08-04 | 123 | 0 |
| K870805 | MODEL 840 TRANSCUTAN. OXYGEN/CARBON DIOX. MONITOR | Novametrix Medical Systems, Inc. | 1987-05-27 | 85 | 0 |
| K853124 | NOVAMETRIX PULSE OXIMETER, MODEL 500 | Novametrix Medical Systems, Inc. | 1985-11-06 | 104 | 0 |
| K850487 | NOVAMETRIX 350 RECORDER-PAPER CHART RECORDER | Novametrix Medical Systems, Inc. | 1985-03-29 | 50 | 0 |
| K844010 | CPNOGARD CAPNOMETER 1250 | Novametrix Medical Systems, Inc. | 1985-02-21 | 132 | 0 |
| K844253 | NOVAMETRIX 811 TRANSCO2M PORTABLE TRANSCUTANEOUS 2 | Novametrix Medical Systems, Inc. | 1985-01-10 | 69 | 0 |
| K844079 | NOVAMETRIX 860 PROTA. TRANSCUTANEOUS OXYGEN | Novametrix Medical Systems, Inc. | 1984-11-30 | 42 | 0 |
| K842374 | NOVAMETRIX 850 TRANSCUTANEOUS OXYGEN | Novametrix Medical Systems, Inc. | 1984-09-17 | 91 | 0 |
| K840993 | TRANSCUTANEOUS 800-OXYGEN MONITORS/801 | Novametrix Medical Systems, Inc. | 1984-04-24 | 47 | 0 |
| K840560 | NEONATAL PHYSIOLOGICAL MONITOR 903 | Novametrix Medical Systems, Inc. | 1984-04-17 | 69 | 0 |
| K840392 | NOVOX OXYGEN ANALYZER 400 | Novametrix Medical Systems, Inc. | 1984-02-27 | 28 | 0 |
| K831578 | PHYSIOLOGICAL MONITOR #902 | Novametrix Medical Systems, Inc. | 1983-08-12 | 87 | 0 |
| K821720 | PHYSIOLOGICAL DISPLAY SYSTEM, MODEL 1000 | Novametrix Medical Systems, Inc. | 1982-06-25 | 15 | 0 |
| K813350 | NOVAMETRIX MODEL 807 TRANSCUT. MONITOR | Novametrix Medical Systems, Inc. | 1982-02-12 | 77 | 0 |
| K813352 | NOVAMETRIX MODEL 816A TRANSCUT. OXYGEN | Novametrix Medical Systems, Inc. | 1982-01-07 | 41 | 0 |
| K813351 | NOVAMETRIX NAVAGRAPH MODEL 312 RECORDER | Novametrix Medical Systems, Inc. | 1981-12-31 | 34 | 0 |
| K811893 | NOVAMETRIX PHYSIOLOGICAL MONITOR #910 | Novametrix Medical Systems, Inc. | 1981-09-08 | 69 | 0 |
| K811453 | NOVATRACER RECORDER | Novametrix Medical Systems, Inc. | 1981-07-10 | 49 | 0 |
| K802955 | MONITOR, AIRWAY PRESSURE | Novametrix Medical Systems, Inc. | 1980-12-19 | 29 | 0 |
| K800988 | NOVAMETRIX TCOMETTE #809 TRANS. MONITOR | Novametrix Medical Systems, Inc. | 1980-05-28 | 34 | 0 |
| K792722 | NOVAMETRIX CPAP NASAL CANNULA | Novametrix Medical Systems, Inc. | 1980-01-24 | 24 | 0 |
| K792011 | TC02M PRECISION GAS CALIBRATOR | Novametrix Medical Systems, Inc. | 1979-11-16 | 42 | 0 |
| K792009 | TC02 M OXYGEN ELECTRODE CONTACT | Novametrix Medical Systems, Inc. | 1979-10-26 | 21 | 0 |
| K792010 | TC02M ELECTRODE ADHESIVE RINGS | Novametrix Medical Systems, Inc. | 1979-10-26 | 21 | 0 |
| K791152 | TCO2M MODEL 818 | Novametrix Medical Systems, Inc. | 1979-08-03 | 45 | 0 |
| K781713 | ADAPTER, C/D SUCTION | Novametrix Medical Systems, Inc. | 1978-12-12 | 67 | 0 |
| K781714 | PNEUMOGARD MODEL 1230 | Novametrix Medical Systems, Inc. | 1978-11-27 | 52 | 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