Panels › Anesthesiology › Product code NHJ · Class 2
Device, Positive Pressure Breathing, Intermittent
Regulation 868.5905
2510(k)s in 12 months (26 all time)
12recalls in 12 months (17 all time)
11recalls that name a 510(k)
Top companies in NHJ
| Company | 510(k)s | Recalls |
|---|---|---|
| Baxter Healthcare Corporation | 0 | 10 |
| Percussionaire Corp. | 2 | 7 |
| Abmrc, LLC | 4 | 0 |
| Hill-Rom Services Pte, Ltd. | 4 | 0 |
| Dima Italia Srl | 3 | 0 |
| Vortran Medical Technology 1, Inc. | 3 | 0 |
| J. H. Emerson Co. | 2 | 0 |
| Lung Assist, Inc. | 2 | 0 |
| Breas Medical AB | 1 | 0 |
| Comedica , Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 24, 2026 | K260604 | BiWaze Clear System Abmrc, LLC | NHJ |
| Jun 16, 2026 | K253001 | KT Airway Clearance Device II (KT-3); KT Airway Clearance Device II (KT-5) Hunan Ruijiong Biotech Co., Ltd., CN | NHJ |
| May 16, 2025 | K242438 | Clearo Breas Medical AB, SE | NHJ |
| Apr 8, 2024 | K231728 | BiWaze Clear System Abmrc, LLC | NHJ |
| Dec 21, 2022 | K213564 | BiWaze Clear System Abmrc, LLC | NHJ |
| May 26, 2020 | K200988 | Maximus System Hill-Rom Services Pte, Ltd., SG | NHJ |
| Mar 27, 2020 | K191912 | BiWaze Cough Abmrc, LLC | NHJ |
| Feb 14, 2020 | K192143 | Maximus System Hill-Rom Services Pte, Ltd., SG | NHJ |
| Mar 17, 2016 | K151689 | MetaNeb 4 System Hill-Rom Services Pte, Ltd., SG | NHJ |
| Oct 16, 2014 | K140598 | PEGASO COUGH, PEGASO A-COUGH, PEGASO A-COUGH PERC Dima Italia Srl, IT | NHJ |
| Oct 3, 2014 | K140605 | MINIPEGASO COUGH, MINIPEGASO A-COUGH, MINIPEGASO A-COUG PERC Dima Italia Srl, IT | NHJ |
| Mar 28, 2014 | K132988 | VITAL COUGH Lung Assist, Inc. | NHJ |
| Apr 25, 2013 | K124032 | METANEB Hill-Rom Services Pte, Ltd., SG | NHJ |
| Feb 21, 2013 | K113549 | COMFORT COUGH Seoil Pacific Corp., KR | NHJ |
| Dec 14, 2012 | K121955 | COUGHASSIST T70 DEVICE Respironics, Inc. | NHJ |
| Sep 12, 2012 | K120277 | VITAL COUGH Lung Assist, Inc. | NHJ |
| Jan 7, 2008 | K072292 | NEGAVENT PLUS PEGASO COUGH, MODEL: DA-3 PLUS Dima Italia Srl | NHJ |
| Dec 1, 2005 | K051964 | POWERNEB Comedica , Inc. | NHJ |
| Feb 23, 2001 | K003684 | PERCUSSIVENEB, MODEL PN-2001 Vortran Medical Technology 1, Inc. | NHJ |
| Nov 22, 2000 | K002598 | EMERSON COUGH ASSIST MODEL CA-3000 W/AUTOMATIC TIMING AND MODEL CM-3000 W/MANUAL TIMING J. H. Emerson Co. | NHJ |
| Nov 3, 1998 | K982016 | PIPER IPPB MODEL 2055 Vortran Medical Technology 1, Inc. | NHJ |
| Sep 17, 1998 | K981726 | PERCUSSIVETECH HF, MODEL 2001 Vortran Medical Technology 1, Inc. | NHJ |
| Nov 17, 1992 | K924174 | EMERSON IN-EXSUFFLATOR, MODELS 2-CM & 2-CA J. H. Emerson Co. | NHJ |
| Apr 18, 1991 | K905236 | IPV PERCUSSIONATOR FAMILY & RELATED ACCESSORIES Percussionaire Corp. | NHJ |
| Oct 30, 1989 | K895485 | BIRD (IPV) NONCONTINUOUS VENTILATORS Percussionaire Corp. | NHJ |
| Sep 27, 1978 | K781232 | IPPB ASSEMBLY W/NEBULIZER Rtec | NHJ |
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