Regulator, Vacuum
General Hospital · 21 CFR 880.6740
Recent MDR events
99 adverse event reports on file
- MEDLINEJul 22, 2026MalfunctionMedline Industries, Lp1417592-2026-07483
- MEDLINEJul 22, 2026MalfunctionMedline Industries, Lp1417592-2026-07094
- MEDLINEJun 24, 2026MalfunctionMedline Industries, Lp1417592-2026-03088
- MEDLINEJun 19, 2026MalfunctionMedline Industries, Lp1417592-2026-02679
- MEDLINEJun 19, 2026MalfunctionMedline Industries, Lp1417592-2026-02680
- MEDLINEJun 16, 2026MalfunctionMedline Industries, Lp1417592-2026-02538
- MEDLINEMay 23, 2026MalfunctionMedline Industries, Lp1417592-2026-01673
- MEDLINEMay 22, 2026MalfunctionMedline Industries, Lp1417592-2026-01596
- PRECISION MEDICAL INC.Feb 27, 2026MalfunctionPrecision Medical, Inc.24469452
- OHIO MEDICAL VACUUM REGULATORAug 25, 2025MalfunctionOhio Medical Llc22886384
Event type breakdown
Recalls
4 recall events for this product code
- Boehringer Laboratories, Inc.TerminatedNov 17, 2005
Boehringer Suction Regulator Model number 3704
Condition exists that prevents complete shutoff of the valve
Z-0155-06 · View FDA record ↗ - Boehringer Laboratories, Inc.TerminatedNov 17, 2005
Boehringer Suction Regulator Model number 3704D3
Condition exists that prevents complete shutoff of the valve
Z-0156-06 · View FDA record ↗ - Boehringer Laboratories, Inc.TerminatedNov 17, 2005
Boehringer Suction Regulator Model number 3714
Condition exists that prevents complete shutoff of the valve
Z-0157-06 · View FDA record ↗ - Ohio Medical CorporationTerminatedUnknown
Vacuum Regulator, Push-T-Set Intermittent Suction Unit (PTS-ISU)
Final quality control testing was not completed before the devices were distributed..
Z-2410-2018 · View FDA record ↗
Registered firms
35 firms currently registered for this product code
Steritech, Inc.
SALINAS, PR, US
Sterigenics Belgium Petit Rechain S.a.
Verviers Liege, BE
Hospital Equipment Mfg. Co.
NOIDA Uttar Pradesh, IN
Swann-morton(services) Limited
Owlerton Green Sheffield, GB
Mindray Ds Usa, Inc.
Mahwah, NJ, US
Shenzhen Mindray Bio-medical Electronics Co., Ltd.
Shenzhen Guangdong, CN
Curaco Inc
Seongnam-si Gyeonggi, KR
Precision Medical, Inc.
NORTHAMPTON, PA, US
J Summit Co., Ltd.
Chomthong Krung Thep Maha Nakhon, TH
Dtr Medical Ltd
Swansea, GB
Boehringer Laboratories, Llc
Phoenixville, PA, US
Hersill, S.l.
MOSTOLES (MADRID) Madrid (Province), ES
Ohio Medical Llc
Gurnee, IL, US
Suzhou Jinsheng Plastic Co., Ltd.
SUZHOU Jiangsu, CN
Gentec (shanghai) Corporation
SHANGHAI, CN
Andersen Caledonia Ltd
Bellshill Scotland, GB
Fisher & Paykel Healthcare, Inc.
IRVINE, CA, US
Tri-tech Medical, Inc.
AVON, OH, US
Bothwin Medical Technology (sg) Pte. Ltd.
Singapore Central Singapore, SG
Acare Technology Co., Ltd.
New Taipei City, TW
Isomedix Operations Inc.
WHIPPANY, NJ, US
510(k) clearances
21 clearances for this product code
- Boehringer LaboratoriesJan 8, 2002
K013976 · BOEHRINGER MRI SUCTION REGULATORY
- Precision Medical, Inc.Dec 22, 1994
K944479 · PM3300 INTERMITTENT VACUUM
- Engineered Orthopedic Technologies, Inc.Jul 21, 1994
K942747 · MALCOLM-LYNN(TM) EOT SUCTION REG VALVE(TM) (SRV) )
- Boehringer LaboratoriesMar 28, 1994
K933232 · BOEHRINGER LABORATORIES SUCTION REGULATOR, MODIFIED
- Hill-Rom, Inc.Jul 27, 1993
K926140 · VACUUM POWER BODY FLUID SUCTION APPARATUS
- Precision Medical, Inc.Mar 4, 1993
K922817 · PM3000 & PM3100 VACUUM REGULATOR
- Ohmeda MedicalOct 19, 1988
K883229 · OHMEDA CONTINUOUS SUCTION REGULATOR
- Timeter Instrument Corp.Feb 22, 1988
K875074 · VACUMATE INTERMITTENT/CONTINUOUS CONTROLLER,VM2000