Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Nellcor Puritan Bennett, Inc. · Predicate Candidate Screening
42 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
89 daysmedian FDA review time
238 days90th percentile
42clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K070408 | DURAMAX REUSABLE OXIMETRY SENSOR | Nellcor Puritan Bennett, Inc. | 2007-05-25 | 102 | 0 |
| K060576 | NELLCOR OXIMAX N-600X PULSE OXIMETER | Nellcor Puritan Bennett, Inc. | 2006-08-14 | 161 | 0 |
| K051271 | OXIMAX NEOMAX ADHESIVE FOREHEAD REFLECTANCE OXIMETRY SENSOR | Nellcor Puritan Bennett, Inc. | 2006-01-10 | 238 | 0 |
| K052186 | NELLCOR OXIMAX PULSE OXIMETRY SENSONS (MAX-A, MAX-AL, MAX-N, | Nellcor Puritan Bennett, Inc. | 2005-11-10 | 91 | 0 |
| K051352 | OXIMAX NPB-40 HANDHELD PULSE OXIMETER | Nellcor Puritan Bennett, Inc. | 2005-08-11 | 79 | 0 |
| K050072 | GOODKNIGHT 425ST | Nellcor Puritan Bennett, Inc. | 2005-06-13 | 152 | 0 |
| K033973 | OXISENSOR II RECYCLED SENSOR AND OXIMAX RECYCLED SENSOR | Nellcor Puritan Bennett, Inc. | 2004-12-13 | 357 | 0 |
| K030787 | SHILEY FLEXTRA TRACHEOSTOMY TUBE | Nellcor Puritan Bennett, Inc. | 2003-11-14 | 247 | 1 |
| K030930 | OXIMAX SOFTCARE SENSORS, MODELS SC-A, SC-PR, SC-NEO, SC-N | Nellcor Puritan Bennett, Inc. | 2003-05-23 | 59 | 0 |
| K023494 | NELLCOR INDGO MANUAL RESUSCITATOR | Nellcor Puritan Bennett, Inc. | 2003-02-07 | 112 | 0 |
| K022819 | NELLCOR N-200 PULSE OXIMETER, MODEL N-200 | Nellcor Puritan Bennett, Inc. | 2002-09-24 | 29 | 0 |
| K020357 | 800 SERIES EASYNEB NEBULIZER | Nellcor Puritan Bennett, Inc. | 2002-08-07 | 184 | 1 |
| K021089 | OXIMAX MAX-FAST ADHESIVE FOREHEAD SENSOR | Nellcor Puritan Bennett, Inc. | 2002-06-19 | 76 | 0 |
| K021090 | OXIMAX N-550 PULSE OXIMETER,MODEL N-550 PULSE OXIMETER | Nellcor Puritan Bennett, Inc. | 2002-05-08 | 34 | 0 |
| K020604 | WARMTOUCH PATIENT WARMING SYSTEM, MODEL 5300 | Nellcor Puritan Bennett, Inc. | 2002-04-23 | 57 | 0 |
| K012891 | OXIMAX PULSE OXIMETRY SYSTEM WITH N-595 PULSE OXIMETER AND O | Nellcor Puritan Bennett, Inc. | 2002-03-07 | 191 | 1 |
| K014121 | WARMTOUCH CARDIAC BLANKET,CATALOG # 503-0860 | Nellcor Puritan Bennett, Inc. | 2002-01-11 | 25 | 0 |
| K002686 | ACHIEVA VENTILATOR Y-ACH+E, ACHIEVA PS VENTILATOR Y-ACHPS+E, | Nellcor Puritan Bennett, Inc. | 2000-10-18 | 51 | 0 |
| K993637 | N-395 PULSE OXIMETER, WITH EXTENDED DEVICE CLAIMS | Nellcor Puritan Bennett, Inc. | 1999-11-24 | 27 | 1 |
| K990177 | NELLCOR PURITAN BENNETT ACHIEVA VENTILATOR AND REPORT GENERA | Nellcor Puritan Bennett, Inc. | 1999-11-18 | 303 | 0 |
| K991823 | N-395 PULSE OXIMETER, MODEL N-395 | Nellcor Puritan Bennett, Inc. | 1999-08-25 | 89 | 0 |
| K990565 | SUZANNE | Nellcor Puritan Bennett, Inc. | 1999-08-18 | 177 | 0 |
| K983274 | STARTRACK INFANT GRAPHICS MONITOR | Nellcor Puritan Bennett, Inc. | 1998-12-09 | 83 | 0 |
| K982728 | NELLCOR PURITAN BENNETT UNIPROBE ADAPTER CABLE, UP12A, UP12B | Nellcor Puritan Bennett, Inc. | 1998-12-07 | 124 | 0 |
| K980365 | GOODKNIGHT 418 CPAP SYSTEM | Nellcor Puritan Bennett, Inc. | 1998-07-22 | 174 | 0 |
| K980441 | SPIROMETER MODEL NPB-500 | Nellcor Puritan Bennett, Inc. | 1998-04-30 | 85 | 0 |
| K973419 | DMR PLUS DISPOSABLE MANUAL RESUSCITATOR | Nellcor Puritan Bennett, Inc. | 1998-03-25 | 196 | 0 |
| K973147 | NPB-295 PULSE OXIMETER | Nellcor Puritan Bennett, Inc. | 1997-11-14 | 84 | 1 |
| K972837 | NPB-290 PULSE OXIMETER (NPB-290) | Nellcor Puritan Bennett, Inc. | 1997-10-21 | 82 | 1 |
| K972468 | NPB-195 PULSE OXIMETER | Nellcor Puritan Bennett, Inc. | 1997-09-25 | 86 | 0 |
| K972248 | NELLCOR PURITAN BENNETT GEMINI | Nellcor Puritan Bennett, Inc. | 1997-09-12 | 88 | 0 |
| K971946 | NPB-190 PULSE OXIMETER (NPB-190) | Nellcor Puritan Bennett, Inc. | 1997-08-25 | 90 | 0 |
| K964019 | MORPHEE PLUS ALPHA | Nellcor Puritan Bennett, Inc. | 1997-06-18 | 254 | 0 |
| K964543 | INFRASONICS ADULT VENTILATOR TRENDING OPTION | Nellcor Puritan Bennett, Inc. | 1997-02-14 | 93 | 0 |
| K964494 | SLEEPWIZARD | Nellcor Puritan Bennett, Inc. | 1997-02-04 | 88 | 0 |
| K964516 | TAP | Nellcor Puritan Bennett, Inc. | 1997-01-24 | 80 | 0 |
| K963707 | NELLCOR PURITAN BENNETT NPB-40 HANDHELD PULSE(NPB-40) | Nellcor Puritan Bennett, Inc. | 1996-12-13 | 88 | 0 |
| K963400 | NELLCOR SYMPHONY N-3000 PATIENT MONITOR WITH SPO2 AND ECG AN | Nellcor Puritan Bennett, Inc. | 1996-11-26 | 89 | 0 |
| K962516 | TAP ANTI-SNORING DEVICE | Nellcor Puritan Bennett, Inc. | 1996-09-10 | 75 | 0 |
| K961450 | SCORE SOFTWARE | Nellcor Puritan Bennett, Inc. | 1996-08-01 | 108 | 0 |
| K955642 | NELLCOR SYMPHONY N-3000 PATIENT MONITOR W/SP02 & ECG/N-3200 | Nellcor Puritan Bennett, Inc. | 1996-07-02 | 203 | 0 |
| K960468 | DMR/CO2 COMBO KTI | Nellcor Puritan Bennett, Inc. | 1996-04-26 | 85 | 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