Cleared Traditional

K162562 - OPT-SHIELD AIR, SUPINE (FDA 510(k) Clearance)

Also includes:
OPT-SHIELD, LITHOTOMY

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 157
Devices cleared under the same product code (DWJ) and FDA review panel - the closest regulatory comparables to K162562.
Hot Pink Pad Warming System
K260903 · Xodus Medical, Inc. · Apr 2026
Warming System
K252861 · Hangzhou Tappa Medical Technology Co., Ltd. · Apr 2026
Arctic Sun Temperature Management System (Model 5000)
K251974 · Medivance, Inc. · Oct 2025
Celsi Warmer
K242964 · Hadleigh Health Technologies · Jun 2025
Arctic Sun Stat Temperature Management System
K243942 · Medivance, Inc. · Apr 2025
HotDog Warming Mattress + Return Electrode
K232627 · Augustine Temperature Management, LLC · Apr 2024