ClearanceBrief
Company · US

Boehringer Laboratories

FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 2026. Name variants (Inc, Corp, punctuation) are merged.

44510(k) clearances (1 in 12 months)
6recalls (0 in 12 months)
4recalls that name a 510(k)

Product codes

CodeDeviceRecords
CACApparatus, Autotransfusion13
KDPRegulator, Vacuum7
GCXApparatus, Suction, Operating-Room, Wall Vacuum Powered4
KNTTubes, Gastrointestinal (And Accessories)4
BZKSpirometer, Monitoring (W/Wo Alarm)3
GCJLaparoscope, General & Plastic Surgery3
GFABlade, Saw, General & Plastic Surgery, Surgical2
KDQBottle, Collection, Vacuum2
BWFSpirometer, Therapeutic (Incentive)1
BYEAttachment, Breathing, Positive End Expiratory Pressure1
CAFNebulizer (Direct Patient Interface)1
CBPValve, Non-Rebreathing1
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase1
CFJNad Reduction/Nadh Oxidation, Lactate Dehydrogenase1
CJENitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes1
DWLStocking, Medical Support (To Prevent Pooling Of Blood In Legs)1
GCYApparatus, Suction, Single Patient Use, Portable, Nonpowered1
JCXApparatus, Suction, Ward Use, Portable, Ac-Powered1
JOHTube Tracheostomy And Tube Cuff1
OMPNegative Pressure Wound Therapy Powered Suction Pump1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Aug 14, 2026K26189052Fr ViSiGi LUX™; 52Fr ViSiGi 3D®
Boehringer Laboratories, LLC
KNT
Jul 2, 2025K243399Boehringer Laboratories Liver Retractor
Boehringer Laboratories, LLC
GCJ
May 6, 2024K234033ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340)
Boehringer Laboratories, LLC
KNT
Jan 26, 2024K234145ViSiGi 3D Gastric Sizing Tube
Boehringer Laboratories
KNT
Sep 11, 2015K151990Tissue Removal System
Boehringer Laboratories, LLC
GCJ
Jun 19, 2015K150781Tissue Removal Pouch
Boehringer Laboratories, LLC
GCJ
Mar 28, 2013K130483BOEHRINGER GASTRIC SIZING TUBE
Boehringer Laboratories, LLC
KNT
Jul 11, 2006K061788BOEHRINGER LABORATORIES SUCTION PUMP SYSTEM
Boehringer Laboratories
OMP
Mar 3, 2006K060277BOEHRINGER LABORATORIES SUCTION PUMP SYSTEM
Boehringer Laboratories
JCX
May 15, 2002K020538BOEHRINGER LABORATORIES PNEUMATIC AMBULATORY COMPRESSION SYSTEM 8200 SERIES
Boehringer Laboratories
DWL
Feb 6, 2002K014187AUTOVAC ORTHOPEDIC AUTOTRANSFUSION SYSTEM
Boehringer Laboratories
CAC
Jan 8, 2002K013976BOEHRINGER MRI SUCTION REGULATORY
Boehringer Laboratories
KDP
Jun 20, 1996K955010AUTOVAC BP SYSTE, 2000 SERIES
Boehringer Laboratories
CAC
Oct 19, 1995K945775BOEHRINGER AUTOVAC(R) 7900 SERIES
Boehringer Laboratories
CAC
Jul 6, 1994K932093AUTOVAC CLOSED WOUND AUTOTRANSFUSION SYSTEM,7920 S
Boehringer Laboratories
CAC
Mar 28, 1994K933232BOEHRINGER LABORATORIES SUCTION REGULATOR, MODIFIED
Boehringer Laboratories
KDP
Feb 22, 1994K930615AUTOVAC CLOSED WOUND SUCTION SYSTEM
Boehringer Laboratories
GCY
Jan 26, 1994K934390OSCILLATING BONE SAW BLADE, 6200 SERIES
Boehringer Laboratories
GFA
Feb 5, 1993K924894AUTOVAC 7900 SERIES
Boehringer Laboratories
CAC
Jan 21, 1993K924953FLUID COOLED BONE SAW BLADE, 6000 SERIES
Boehringer Laboratories
GFA
Sep 6, 1991K904164AUTOVAC (R) AUTOTRANSFUSION SYSTEM, 7900 MODIFIED
Boehringer Laboratories
CAC
Jan 16, 1991K904888AUTOWAND(TM) 7XXX SERIES, MODIFICATION
Boehringer Laboratories
CAC
Jul 24, 1990K902059AUTOWAND(TM) 7XXX SERIES
Boehringer Laboratories
CAC
Jun 18, 1990K901138AUTOVAC(R) AUTOTRANSFUSION SYSTEM, 7900 SERIES
Boehringer Laboratories
CAC
Mar 13, 1990K895297AUTOTRANSFUSION RESERVIOR MODEL 7900 MODIFICATION
Boehringer Laboratories
CAC
Mar 3, 1989K884103REMOTE VACUUM BOOSTER SYSTEM, 7600 SERIES
Boehringer Laboratories
GCX
Jun 14, 1988K881129AUTO-VAC INTRAOPERATIVE AUTOTRANS. RESERVOIR #7904
Boehringer Laboratories
CAC
Mar 2, 1988K873521BRONCHODILATOR TEE - 9056 SERIES
Boehringer Laboratories
CAF
Oct 17, 1986K862684AUTO-VAC (TM) AUTOTRANSFUSION RESERV, MODEL 7900
Boehringer Laboratories
CAC
Apr 28, 1986K861025T-VAC PLEURAL DRAINAGE UNIT, 7800 SERIES
Boehringer Laboratories
KDQ
Mar 13, 1986K855074FILTERED VACUUM SAFETY TRAP BOTTLE
Boehringer Laboratories
KDQ
Oct 16, 1985K853155BOEHRINGER LAB SUCTION INTERRUPTER
Boehringer Laboratories
KDP
Aug 23, 1985K853095BOEHRINGER LABORATORIES SUCTION INTERMITTOR
Boehringer Laboratories
GCX
Mar 4, 1985K850200SUCTION REGULATOR 7700 SERIES
Boehringer Laboratories
KDP
Sep 26, 1983K832868RESUSCITATION VALVE
Boehringer Laboratories
CBP
Jul 12, 1983K822689PORTABLE MONITORING & SCREENING SPIROM.
Boehringer Laboratories
BZK
May 8, 1980K800755BOEHRINGER LABS AMBULATORY PEEP VALVE
Boehringer Laboratories
BYE
Nov 27, 1979K792155CO 2 METER
Boehringer Laboratories
CCK
Apr 4, 1979K790248NICOTINAMIDE-ADENINE AINUCLEOTIDE (NAD)
Boehringer Laboratories
CFJ
Jan 31, 1979K782145SPIROMETER, MINI POSITIVE
Boehringer Laboratories
BZK
Aug 26, 1977K771532SPIROMETEO & LUNG EXERCISER, 4601
Boehringer Laboratories
BWF
Jun 2, 1977K770406TECHNICON SMA & AAII SYSTEMS
Boehringer Laboratories
CJE
Dec 9, 1976K760971POSITIVE DISPLACEMENT SPIROMETER
Boehringer Laboratories
BZK
Sep 13, 1976K760453REGULATOR, PRESSURE, CUFF
Boehringer Laboratories
JOH

Latest recalls

DateFirm and productCodeLinked 510(k)
Nov 17, 2005Boehringer Laboratories, Inc.
Boehringer Suction Regulator Model number 3714
Terminated		 KDPK853095
Nov 17, 2005Boehringer Laboratories, Inc.
Boehringer Suction Regulator Model number 3704D3
Terminated		 KDPK853095
Nov 17, 2005Boehringer Laboratories, Inc.
Boehringer Suction Regulator Model number 3704
Terminated		 KDPK853095
Jul 20, 2004Boehringer Laboratories Inc
Boehringer Replacement Gauge Model 9071, Lot Number 200405.
Terminated		 GCXNone listed
Jul 20, 2004Boehringer Laboratories Inc
Boheringer Suction Regulator Model 7702L, Lot number 04D Boehinger Replacement Gauge, Model 9071, Lot number 200405.
Terminated		 GCXNone listed
Dec 17, 2003Boehringer Laboratories Inc
Autovac TL. Autotransfusion System for Orthopedic Wound Drainage. The product is shipped in cartons containing 6 units
Terminated		 CACK932093
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