SHIKANI MEDICAL LLC

FDA Device Registration & Listing · Lutherville, MD, US · Registration 3008278458

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3008278458
FEI Number
3008278458
Entity Name
SHIKANI MEDICAL LLC
City/State/Country
Lutherville, MD, US
Establishment Address
1629 York Road, Lutherville, MD 21093, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Shikani Medical LLC (d/b/a The Airway Company) (Owner Number: 10031493)
Owner / Operator Contact Address
1629 York Road, Lutherville, MD 21093, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K100995
PMA Number
N/A

All Registered Proprietary Names

HME for use with Shikani Speaking valves Shikani speaking valves SSV2 speaking valve

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
BYD Condenser, Heat And Moisture (Artificial Nose) Anesthesiology Class 1 868.5375 2011-07-20
JOH Tube Tracheostomy And Tube Cuff Anesthesiology Class 2 868.5800 2010-06-30

Official Correspondent

Patrick Shikani

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Shikani Medical LLC (d/b/a The Airway Company)
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K142298 Covidien Shiley Neonatal, Pediatric & Pediatric Long Tracheostomy Tubes with TaperGuard Cuff 2015-02-13
K182861 Covidien Shiley Neonatal/Pediatric Tracheostomy Tube 2019-03-22
K142296 Covidien Shiley Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Disposable Inner Cannula 2015-02-24

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0044-2017 Teleflex Medical 2
Willy Rusch GmbH Tracheostomy Tube Set Cannulation of tracheotomised patients, particularly in the case of a narrow tracheostoma and narrow-lumen tracheas. When using cannulas with curr. For short term intermittent inflation.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008278458. Last updated year: 2026. Please use registration number 3008278458 when referencing this establishment in official correspondence.
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