Product code KDP— General Hospital

FDA has cleared 21 devices under product code KDP between 1976 and 2002, filed by 15 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20021 clearance
• 19943 clearances
• 19932 clearances
• 19882 clearances
• 19852 clearances
• 19842 clearances
• 19832 clearances
• 19823 clearances
• 19801 clearance
• 19771 clearance
• 19762 clearances

• Boehringer Laboratories4 clearances
• Sorensen Research2 clearances
• Precision Medical, Inc.2 clearances
• Harris-Lake, Inc.2 clearances
• Vital Signs, Inc.1 clearance
• Trimeter Instrument Corp.1 clearance
• Timeter Instrument Corp.1 clearance
• Steridyne Corp.1 clearance
• Ohmeda Medical1 clearance
• Ohio Medical Products1 clearance

• K013976 — BOEHRINGER MRI SUCTION REGULATORYBoehringer Laboratories·2002-01-08
• K944479 — PM3300 INTERMITTENT VACUUMPrecision Medical, Inc.·1994-12-22
• K942747 — MALCOLM-LYNN(TM) EOT SUCTION REG VALVE(TM) (SRV) )Engineered Orthopedic Technologies, Inc.·1994-07-21
• K933232 — BOEHRINGER LABORATORIES SUCTION REGULATOR, MODIFIEDBoehringer Laboratories·1994-03-28
• K926140 — VACUUM POWER BODY FLUID SUCTION APPARATUSHill-Rom, Inc.·1993-07-27
• K922817 — PM3000 & PM3100 VACUUM REGULATORPrecision Medical, Inc.·1993-03-04
• K883229 — OHMEDA CONTINUOUS SUCTION REGULATOROhmeda Medical·1988-10-19
• K875074 — VACUMATE INTERMITTENT/CONTINUOUS CONTROLLER,VM2000Timeter Instrument Corp.·1988-02-22
• K853155 — BOEHRINGER LAB SUCTION INTERRUPTERBoehringer Laboratories·1985-10-16
• K850200 — SUCTION REGULATOR 7700 SERIESBoehringer Laboratories·1985-03-04
• K843591 — INTERCEPTVital Signs, Inc.·1984-10-19
• K834224 — VACUUM REGULATOR 0-2000 MMHG VR-1000Trimeter Instrument Corp.·1984-02-27
• K831505 — THORACIC GAUGE #TG-60 -VACUUM REGULATORSorensen Research·1983-07-12
• K830343 — CONTAINER W/PRIMING SOLUTIONAmerican Hospital Supply Corp.·1983-03-17
• K821314 — FEVER METERSteridyne Corp.·1982-05-28
• K820706 — WATERLESS SEAL & VACUUM REGULATORSorensen Research·1982-04-09
• K820077 — EMERSON THORACIC SUCTION REG. #55-JPJ. H. Emerson Co.·1982-01-28
• K801169 — OHIO FREE FLOW VACUUM REGULATOROhio Medical Products·1980-07-28
• K770944 — INSTATEMPH.I. Silverman, D.Sc.·1977-07-27
• K760316 — REGULATORS, LOW SUCTIONHarris-Lake, Inc.·1976-08-04
• K760317 — REGULATORS, HIGH SUCTIONHarris-Lake, Inc.·1976-08-04