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Medical device manufacturer

Shiley, Inc.

Shiley, Inc. holds 174 FDA 510(k) clearances across 50 product codes. Median elapsed review time is 59 days. openFDA lists no recall records naming the company.

Updated · ingest status · JSON

510(k) clearances
174
Product codes
50
Median review
59 days
Recall records
0

How does FDA spell Shiley, Inc.?

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

Which product codes does Shiley, Inc. file in?

50 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
DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass2165 days
DTNReservoir, Blood, Cardiopulmonary Bypass1473 days
BTOTube, Tracheostomy (W/Wo Connector)1325 days
CACApparatus, Autotransfusion1153 days
DTRHeat-Exchanger, Cardiopulmonary Bypass1149 days
DTZOxygenator, Cardiopulmonary Bypass1085 days
LFJCatheter, Subclavian730 days
BTRTube, Tracheal (W/Wo Connector)515 days
DSYProsthesis, Vascular Graft, Of 6mm And Greater Diameter5128 days
DXECatheter, Embolectomy579 days
DTPDefoamer, Cardiopulmonary Bypass433 days
KRIAccessory Equipment, Cardiopulmonary Bypass416 days
DQOCatheter, Intravascular, Diagnostic359 days
DQRCannula, Catheter320 days
DTMFilter, Blood, Cardiopulmonary Bypass, Arterial Line334 days
DTQConsole, Heart-Lung Machine, Cardiopulmonary Bypass362 days
DWBPump, Blood, Cardiopulmonary Bypass, Roller Type361 days
FLLContinuous Measurement Thermometer315 days
JOHTube Tracheostomy And Tube Cuff363 days
CCEAnalyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling297 days
DQXWire, Guide, Catheter241 days
DTJHolder, Heart-Valve, Prosthesis217 days
DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass269 days
DWPDilator, Vessel, Surgical226 days
DXSGauge, Pressure, Coronary, Cardiopulmonary Bypass249 days

Showing the 25 they file in most, of 50.

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 Shiley, 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 Shiley, Inc. cleared recently?

Most recent 510(k) clearances for this company, newest first.
510(k)DeviceCodeDecisionElapsed days
K920594SHILEY PERFUSION TUBING SETSDTM401
K910991SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEMCAC265
K911876SHILEY PLEXUS(R) VENOUS RESERVOIR, PVR1200DTN102
K910923BCD ADVANCEDDTR35
K901548BIOMEDICAL SENSORS-SHILEY BGM 4000 INTRA BLOOD GASCCC286
K903435SHILEY SPECIALIZED TRACHEOSTOMY TUBEJOH63
K901624SHILEY PLEXUS INTEGRAL RESERVOIR HOLLOW FIBER OXY.DTZ85
K901250PLEXUS 2(TM) INFANT HOLLOW FIBER OXYGENATORDTZ87
K901249PLEXUS 3.5(TM) PEDIATRIC HOLLOW FIBER OXYGENATORDTZ87
K900797STOCKERT SHILEY DUAL PRESSURE CONTROL MODULE XRDXS79

Source: openFDA device/510k · retrieved

Watch what Shiley, 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.