Cleared Traditional

K162562 - OPT-SHIELD AIR

Also marketed or referenced as:
OPT-SHIELD, LITHOTOMY

K162562 is an FDA 510(k) clearance for OPT-SHIELD AIR, manufactured by Bcg Medical, LLC. The device is a Class 2 Cardiovascular device with product code DWJ cleared through the Traditional 510(k) pathway after a 184-day FDA review.

K162562 · Bcg Medical, LLC · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2017
Decision
184d
Days
Class 2
Risk

K162562 is an FDA 510(k) clearance for the OPT-SHIELD AIR, SUPINE. Classified as System, Thermal Regulating (product code DWJ), Class II - Special Controls.

Submitted by Bcg Medical, LLC (San Diego, US). The FDA issued a Cleared decision on March 17, 2017 after a review of 184 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5900 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Bcg Medical, LLC devices

FDA 510(k) Submission Details - K162562

510(k) Number K162562 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 2016
Decision Date March 17, 2017
Days to Decision 184 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d slower than avg
Panel avg: 125d · This submission: 184d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DWJ Device Classification - Class 2, Special Controls

Product Code DWJ System, Thermal Regulating
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5900
Definition If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DWJ System, Thermal Regulating

All 64
Devices cleared under the same product code (DWJ) and FDA review panel - the closest regulatory comparables to K162562.
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WARMTOUCH SURGICAL ACCESS BLANKET, WARMTOUCH TORSO BLANKET
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COVIDIEN WARMTOUCH CONVECTIVE WARMING UNIT
K123083 · Covidien · Apr 2013