Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Nellcor, Inc. — Predicate Candidate Screening
18 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
88 daysmedian FDA review time
521 days90th percentile
18clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K953472 | NELLCOR SYMPHONY N-3100 BLOOD PRESSURE MONITOR | Nellcor, Inc. | 1995-10-20 | 88 | 0 |
| K952316 | NELLCOR SYMPHONY N-3000 PULSE OXIMETER | Nellcor, Inc. | 1995-08-17 | 92 | 0 |
| K952222 | NELLCOR N-20PA PORTABLE PULSE OXIMETER | Nellcor, Inc. | 1995-08-15 | 95 | 0 |
| K942347 | NELLCOR SYMPHONY PULSE OXIMETER MODEL N-3000 | Nellcor, Inc. | 1995-05-12 | 360 | 0 |
| K945947 | NELLCOR SYMPHONY(TM) N-3100 BLOOD PRESSURE MONITOR AND CONNE | Nellcor, Inc. | 1995-03-08 | 92 | 0 |
| K944760 | DURA-Y OXYGEN TRANSDUCER, EAR CLIP | Nellcor, Inc. | 1994-10-17 | 20 | 0 |
| K944400 | PEDI-CAP | Nellcor, Inc. | 1994-09-27 | 19 | 1 |
| K915494 | NELLCOR STAT-CAP AIRWAY CO2 INDICATOR, MODEL N-60 | Nellcor, Inc. | 1993-08-06 | 606 | 0 |
| K915699 | NELLCOR PORTABLE PULSE OXIMETER MODEL N-20 | Nellcor, Inc. | 1993-05-27 | 521 | 0 |
| K913695 | NELLCOR(R) N-180 PULSE OXIMETER | Nellcor, Inc. | 1991-11-13 | 86 | 0 |
| K904039 | REFLECTANCE SENSOR (RS-10) | Nellcor, Inc. | 1990-12-27 | 114 | 0 |
| K901399 | POWERBASE II (PB2) | Nellcor, Inc. | 1990-06-12 | 78 | 0 |
| K896629 | NELLCOR MODEL N-2500 ANESTHESIA SAFETY MONITOR | Nellcor, Inc. | 1990-02-12 | 82 | 0 |
| K884142 | OXINET N-7500 PULSE OXIMETRY NETWORK | Nellcor, Inc. | 1988-12-16 | 77 | 0 |
| K862812 | NELLCOR MVP, MODEL N-1000 | Nellcor, Inc. | 1986-12-22 | 151 | 0 |
| K863784 | NELLCOR N-200 (PULSE OXIMETER) | Nellcor, Inc. | 1986-11-21 | 56 | 0 |
| K844256 | NELLCOR PULSE OXIMETER N-10 | Nellcor, Inc. | 1984-12-27 | 55 | 0 |
| K822909 | PULSE OXIMETER MODEL 100 | Nellcor, Inc. | 1982-11-01 | 32 | 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