Boehringer Lab Suction Interrupter
FDA 510(k) K853155 · Boehringer Laboratories
510(k) numberK853155
Submission
- Device name
- Boehringer Lab Suction Interrupter
- Applicant
- Boehringer Laboratories
Norristown, PA, US - Received
- July 29, 1985
- Decision date
- October 16, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KDP – Regulator, Vacuum
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6740
- Specialty
- General Hospital
Other 510(k)s with product code KDP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K013976 | Boehringer MRI Suction RegulatoryKDP · Traditional | Boehringer Laboratories | 01/08/2002SE |
| K944479 | PM3300 Intermittent VacuumKDP · Traditional | Precision Medical, Inc. | 12/22/1994SE |
| K942747 | Malcolm-Lynn(Tm) Eot Suction Reg Valve(Tm) (SRV) )KDP · Traditional | Engineered Orthopedic Technologies, Inc. | 07/21/1994SE |
| K933232 | Boehringer Laboratories Suction Regulator, ModifiedKDP · Traditional | Boehringer Laboratories | 03/28/1994SE |
| K926140 | Vacuum Power Body Fluid Suction ApparatusKDP · Traditional | Hill-Rom, Inc. | 07/27/1993SE |
| K922817 | PM3000 & PM3100 Vacuum RegulatorKDP · Traditional | Precision Medical, Inc. | 03/04/1993SE |
| K883229 | Ohmeda Continuous Suction RegulatorKDP · Traditional | Ohmeda Medical | 10/19/1988SE |
| K875074 | Vacumate Intermittent/Continuous CONTROLLER,VM2000KDP · Traditional | Timeter Instrument Corp. | 02/22/1988SE |
| K850200 | Suction Regulator 7700 SeriesKDP · Traditional | Boehringer Laboratories | 03/04/1985SE |
| K843591 | InterceptKDP · Traditional | Vital Signs, Inc. | 10/19/1984SE |
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| 510(k) | Device | Decision |
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| K261890 | 52Fr ViSiGi LUX; 52Fr ViSiGi 3D®KNT · Special | 08/14/2026SE |
| K243399 | Boehringer Laboratories Liver RetractorGCJ · Traditional | 07/02/2025SE |
| K234033 | ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340)KNT · Traditional | 05/06/2024SE |
| K234145 | ViSiGi 3D Gastric Sizing TubeKNT · Special | 01/26/2024SE |
| K151990 | Tissue Removal SystemGCJ · Traditional | 09/11/2015SE |
| K150781 | Tissue Removal PouchGCJ · Traditional | 06/19/2015SE |
| K130483 | Boehringer Gastric Sizing TubeKNT · Traditional | 03/28/2013SE |
| K061788 | Boehringer Laboratories Suction Pump SystemOMP · Traditional | 07/11/2006SE |
| K060277 | Boehringer Laboratories Suction Pump SystemJCX · Traditional | 03/03/2006SE |
| K020538 | Boehringer Laboratories Pneumatic Ambulatory Compression System 8200 SeriesDWL · Traditional | 05/15/2002SE |
Questions and answers
When was Boehringer Lab Suction Interrupter cleared by the FDA?
Boehringer Lab Suction Interrupter (K853155) received a 510(k) decision of Substantially Equivalent on October 16, 1985, 79 days after the submission was received.
What is the product code of K853155?
The FDA product code is KDP – Regulator, Vacuum, a Class II (moderate risk) device regulated under 21 CFR 880.6740.