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Medical device manufacturer

Quinton, Inc.

Quinton, Inc. holds 164 FDA 510(k) clearances across 57 product codes. Median elapsed review time is 62 days. openFDA lists no recall records naming the company.

Updated · ingest status · JSON

510(k) clearances
164
Product codes
57
Median review
62 days
Recall records
0

How does FDA spell Quinton, Inc.?

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

Which product codes does Quinton, Inc. file in?

57 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
DPSElectrocardiograph1789 days
DQYCatheter, Percutaneous955 days
IOLTreadmill, Powered916 days
FJSCatheter, Peritoneal, Long-Term Indwelling857 days
LFJCatheter, Subclavian856 days
DSIDetector And Alarm, Arrhythmia771 days
DQKComputer, Diagnostic, Programmable672 days
FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days6167 days
DYBIntroducer, Catheter563 days
FKOCatheter, Peritoneal Dialysis, Single Use524 days
MPBCatheter, Hemodialysis, Non-Implanted534 days
DRXElectrode, Electrocardiograph417 days
FKXSystem, Peritoneal, Automatic Delivery450 days
FPASet, Administration, Intravascular462 days
ISDExerciser, Measuring413 days
LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days4140 days
DREDilator, Vessel, For Percutaneous Catheterization348 days
DXJDisplay, Cathode-Ray Tube, Medical327 days
DQOCatheter, Intravascular, Diagnostic285 days
DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)215 days
DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass261 days
DXNSystem, Measurement, Blood-Pressure, Non-Invasive259 days
FIQCannula, A-V Shunt246 days
FJQConnector, Shunt2143 days
FKNAdaptor, Shunt223 days

Showing the 25 they file in most, of 57.

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 Quinton, 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 Quinton, Inc. cleared recently?

Most recent 510(k) clearances for this company, newest first.
510(k)DeviceCodeDecisionElapsed days
K032038PYRAMIS ECG MANAGEMENT SYSTEM MODEL NUMBERS, 92600 AND 92601DQK66
K021906QUINTON Q-CATH, MODEL 000460DQK86
K003576Q-TEL RMS (REHABILITATION MANAGEMENT SYSTEM), MODEL 000503DSI66
K001492QUINTON Q-STRESS, MODEL 000483DPS89
K992908Q-TEL TELEMETRY SYSTEM V. 6.0 (ST)DSI189
K990866QUINTON MEDTRACK CR PLUS TREADMILLISD44
K971397VIEWCATH 3-D CATHETER PULLBACKITX132
K964784SYNERGY CARDIOLOGY INFORMATION SYSTEM (00431)DPS259
K964978VITAL STATISTICS SYSTEM (O-CATH ACCESSORY)DQA160
K955002MAHURKAR 8 FR DUAL LEMEN CATHETERMPB317

Source: openFDA device/510k · retrieved

Watch what Quinton, Inc. files next

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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.