Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Abco Dealers, Inc. · Predicate Candidate Screening

127 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

29 daysmedian FDA review time
79 days90th percentile
127clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K905025DIGITAL THERMOMETER KITSAbco Dealers, Inc.1991-02-07920
K882304DIGITAL THERMOMETER SHEATHS (ORAL AND RECTAL)Abco Dealers, Inc.1988-07-12390
K880892BLOOD COLLECTING NEEDLE AND HOLDERSAbco Dealers, Inc.1988-04-21500
K880894ALLERGIST SYRINGESAbco Dealers, Inc.1988-03-31290
K872875STRETCH GAUZE BANDAGESAbco Dealers, Inc.1987-09-04450
K872874MICROSCOPE COVER GLASSESAbco Dealers, Inc.1987-08-10200
K872797NON-SKID SHOE COVERSAbco Dealers, Inc.1987-08-04200
K871465THERMOMETER SHEATHSAbco Dealers, Inc.1987-05-11270
K862726DISPOSABLE SHOE COVERS AND NURSES CAPSAbco Dealers, Inc.1986-08-01140
K862111ARMBOARDS, REUSABLE AND DISPOSABLEAbco Dealers, Inc.1986-07-08350
K862112MICROSCOPE SLIDESAbco Dealers, Inc.1986-06-13100
K853820SURGICAL TAPES CLOTH, PAPER & PLASTIC-BASEAbco Dealers, Inc.1985-10-16340
K853528STAINLESS STEEL & CARBON STEEL STERILE BLADESAbco Dealers, Inc.1985-09-24320
K851309ABCO PLASTIC UTENSILSAbco Dealers, Inc.1985-07-01900
K850529SHEER ADHESIVE BANDAGES, STERILEAbco Dealers, Inc.1985-05-10880
K851316ABCO SUCTION CANISTERAbco Dealers, Inc.1985-05-08360
K851313ABCO SUTURE REMOVAL KITS-METAL & PLASTIC FORCEPSAbco Dealers, Inc.1985-05-01290
K851315ABCO INSTRUMENT PACKS & TRAYSAbco Dealers, Inc.1985-05-01290
K851314ABCO DRAPES/TOWELSAbco Dealers, Inc.1985-05-01290
K851312ABCO ISOLATION MASKSAbco Dealers, Inc.1985-05-01290
K851173ABCO TRAY CARE KITSAbco Dealers, Inc.1985-04-29350
K850465CERVICAL COLLARS & HEAD HALTERSAbco Dealers, Inc.1985-04-25870
K850470BED PRODUCTSAbco Dealers, Inc.1985-04-01630
K844832WETS & DRIESAbco Dealers, Inc.1985-01-29480
K844106SYRINGE W/NEEDLE COMBIN & SYRINGE ONLYAbco Dealers, Inc.1985-01-14830
K833246TYMPANOSTOMY TUBES-VARIOUSAbco Dealers, Inc.1985-01-044840
K843892MICRO HEMATOCRIT CAPILLARY TUBESAbco Dealers, Inc.1984-11-13410
K843720COTTON TIPPED APPLICATORS, SINGLEAbco Dealers, Inc.1984-10-04100
K843016VINYL EXAM GLOVES, NON-STERILEAbco Dealers, Inc.1984-08-17170
K841678STERILE, FOLEY CATHETERS W/PTFE COATAbco Dealers, Inc.1984-07-19870
K842016DISPOS. POLY APRONSAbco Dealers, Inc.1984-07-03460
K841677STERILE BLOOD LANCETSAbco Dealers, Inc.1984-06-11490
K841676DISPOSABLE POLY GLOVESAbco Dealers, Inc.1984-05-22290
K832329STERILE IV SET 4 SIZESAbco Dealers, Inc.1983-08-24400
K832281TWO-PLY PAPER FACE FACE MASKAbco Dealers, Inc.1983-08-12310
K830835STERILE 5 IN 1 CONNECTORSAbco Dealers, Inc.1983-04-06210
K830378STERILE, DISPOSABLE, HYPODERMIC NEEDLESAbco Dealers, Inc.1983-03-24480
K830444STERILE, ALL PURPOSE URETHRAL CATHETERAbco Dealers, Inc.1983-03-09270
K822637NASAL SEPTAL BUTTONSAbco Dealers, Inc.1982-09-28280
K821700LATEX PENROSE DRAIN TUBINGAbco Dealers, Inc.1982-06-1680
K821232ONE HAND ANEROID SPHYGMOMANOMETERAbco Dealers, Inc.1982-05-25270
K821177BITE STICKAbco Dealers, Inc.1982-05-21240
K821130PEDIATRIC URINE COLLECTORAbco Dealers, Inc.1982-05-10200
K821028FINGER COTSAbco Dealers, Inc.1982-04-26130
K820589ECONOMY LINE OF TRAYSAbco Dealers, Inc.1982-04-09360
K820590ORTHOPEDIC SOFT GOODSAbco Dealers, Inc.1982-03-26220
K820587WET PACK LINE OF PRODUCTSAbco Dealers, Inc.1982-03-26220
K820584DECUBICARE PADS & ACCESSORIESAbco Dealers, Inc.1982-03-25210
K813376EYE CHARTSAbco Dealers, Inc.1982-01-07370
K813422SCALPELAbco Dealers, Inc.1982-01-05290

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda