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Medical device manufacturer

Abco Dealers, Inc.

Abco Dealers, Inc. holds 127 FDA 510(k) clearances across 70 product codes. Median elapsed review time is 29 days. openFDA lists no recall records naming the company.

Updated · ingest status · JSON

510(k) clearances
127
Product codes
70
Median review
29 days
Recall records
0

How does FDA spell Abco Dealers, Inc.?

FDA publishes this company under a single spelling, so nothing needed merging here. Many manufacturers are not so tidy.

Which product codes does Abco Dealers, Inc. file in?

70 product codes, ranked by how much they file in each.

Product codes this company holds clearances in, with their median elapsed review time in each.
CodeDeviceClearancesMedian reviewLatest
KODCatheter, Urological924 days
FMFSyringe, Piston718 days
DXQBlood Pressure Cuff519 days
EFQGauze/Sponge, Internal529 days
FLLContinuous Measurement Thermometer439 days
KGXTape And Bandage, Adhesive434 days
FLKThermometer, Clinical Mercury311 days
FQMBandage, Elastic339 days
FXPCover, Shoe, Operating-Room320 days
FXXMask, Surgical346 days
KKXDrape, Surgical, Antimicrobial329 days
FCEEnema Kit253 days
FRGWrap, Sterilization229 days
GAXTourniquet, Nonpneumatic28 days
KDQBottle, Collection, Vacuum215 days
KMEBedding, Disposable, Medical270 days
KMJLubricant, Patient222 days
KXFApplicator, Absorbent Tipped, Non-Sterile29 days
NABGauze / Sponge,Nonresorbable For External Use222 days
BTOTube, Tracheostomy (W/Wo Connector)127 days
BYYTube, Aspirating, Flexible, Connecting121 days
CAEAirway, Oropharyngeal, Anesthesiology139 days
DSFRecorder, Paper Chart179 days
DXGComputer, Diagnostic, Pre-Programmed, Single-Function143 days
DXNSystem, Measurement, Blood-Pressure, Non-Invasive157 days

Showing the 25 they file in most, of 70.

Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.

Source: openFDA device/510k · retrieved

Has Abco Dealers, Inc. had a recall?

openFDA lists no recall records naming this company. That is the absence of a record, not a guarantee — and it counts only recalls FDA has published under a spelling we resolved to this company.

Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.

Source: openFDA device/recall · retrieved

What has Abco Dealers, Inc. cleared recently?

Most recent 510(k) clearances for this company, newest first.
510(k)DeviceCodeDecisionElapsed days
K905025DIGITAL THERMOMETER KITSFLL92
K882304DIGITAL THERMOMETER SHEATHS (ORAL AND RECTAL)FLL39
K880892BLOOD COLLECTING NEEDLE AND HOLDERSFMI50
K880894ALLERGIST SYRINGESFMF29
K872875STRETCH GAUZE BANDAGESNAD45
K872874MICROSCOPE COVER GLASSESKES20
K872797NON-SKID SHOE COVERSFXP20
K871465THERMOMETER SHEATHSFLL27
K862726DISPOSABLE SHOE COVERS AND NURSES CAPSFXP14
K862111ARMBOARDS, REUSABLE AND DISPOSABLE—35

Source: openFDA device/510k · retrieved

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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.