Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MNT — Predicate Candidate Screening
25 FDA 510(k) clearances under this product code; the 50 most recent screened below.
232 daysmedian FDA review time
396 days90th percentile
25clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252182 | SV70 Ventilator (SV70) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2026-04-06 | 269 | 0 |
| K242931 | HFT750U | Mekics Co., Ltd. | 2025-05-15 | 232 | 0 |
| K240779 | Vivo 3 | Breas Medical AB | 2024-12-13 | 267 | 0 |
| K233643 | F&P Airvo 3 NIV (PT311US) | Fisher & Paykel Healthcare, Ltd. | 2024-08-09 | 270 | 0 |
| K230173 | Servo-air Lite Ventilator System | Maquet Critical Care AB | 2023-07-06 | 167 | 0 |
| K213521 | Nihon Kohden NKV-330 Ventilator System | Nihon Kohden Orangemed, Inc. | 2022-07-01 | 240 | 0 |
| K191624 | F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphy | Fisher & Paykel Healthcare Limited | 2020-03-09 | 265 | 0 |
| K170367 | Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyx | Fisher and Paykel Healthcare Limited | 2017-08-24 | 199 | 0 |
| K122715 | STELLAR 150 | Resmed Germany, Inc. | 2013-06-17 | 285 | 0 |
| K121623 | BIPAP A 40 VENTILATORY SUPPORT SYSTEM | Respironics, Inc. | 2012-12-14 | 196 | 3 |
| K113640 | STELLAR 150 | Resmed Germany, Inc. | 2012-04-05 | 118 | 0 |
| K102985 | V60 VENTILATOR WITH PPV AND AUTO-TRAK+ SOFTWARE OPTIONS | Respironics, Inc. | 2011-04-05 | 180 | 8 |
| K103167 | STELLAR 150 | Resmed Germany, Inc. | 2011-03-01 | 125 | 0 |
| K090113 | BREAS VIVO 40 SYSTEM | Breas Medical AB | 2009-05-14 | 113 | 0 |
| K082660 | V60 VENTILATOR, MODEL V8000 | Respironics California, Inc. | 2009-01-09 | 119 | 21 |
| K071702 | BREAS VIVO BILEVEL SYSTEM, MODEL VIVO 40 | Breas Medical AB | 2008-02-15 | 239 | 0 |
| K060044 | ACUTE CARE FACE MASK, MODEL RT040 | Fisher & Paykel Healthcare, Ltd. | 2006-04-06 | 90 | 0 |
| K053607 | BREAS VIVO 40 SYSTEM | Breas Medical AB | 2006-03-16 | 79 | 0 |
| K003075 | KNIGHTSTAR 330 VENTILATOR | Mallinckrodt, Inc. | 2001-12-11 | 434 | 1 |
| K990574 | STICK-ON DISPOSABLE NASAL MASK, MODEL 312174, 1001964 | Respironics, Inc. | 1999-05-24 | 90 | 0 |
| K982454 | BIPAP VISION VENTILATORY SUPPORT | Respironics, Inc. | 1998-11-03 | 111 | 2 |
| K974539 | SULLIVAN VPAP II ST VENTILATORY SUPPORT SYSTEM | Resmed, Ltd. | 1998-08-06 | 246 | 0 |
| K973004 | KNIGHTSTAR 335 | Puritan Bennett Corp. | 1998-07-16 | 337 | 0 |
| K955324 | BIPAP S/T-D 30 SYSTEM | Respironics, Inc. | 1996-12-20 | 396 | 0 |
| K951264 | BIPAP MODEL S/T-D | Respironics, Inc. | 1996-07-29 | 496 | 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