Cleared Traditional

FreeStyle Comfort (AS200 / FreeStyle Comfort) (K250671) - FDA 510(k) Clearance

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

K250671 · Caire, Inc. · Anesthesiology device
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Jul 2025
Decision
128d
Days
Class 2
Risk

K250671 is an FDA 510(k) clearance for the FreeStyle Comfort (AS200 / FreeStyle Comfort). Classified as Generator, Oxygen, Portable within the CAW classification (a category for home-use oxygen therapy and respiratory devices), Class II - Special Controls.

Submitted by Caire, Inc. (Ball Ground, US). The FDA issued a Cleared decision on July 11, 2025 after a review of 128 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5440 - the FDA anesthesiology and respiratory device 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 Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Caire, Inc. devices

Submission Details

510(k) Number K250671 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2025
Decision Date July 11, 2025
Days to Decision 128 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 140d · This submission: 128d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CAW Generator, Oxygen, Portable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5440
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - CAW Generator, Oxygen, Portable

All 57
Devices cleared under the same product code (CAW) and FDA review panel - the closest regulatory comparables to K250671.
Portable oxygen concentrator (JAY-1000P)
K243833 · Longfian Scitech Co., Ltd. · Sep 2025
Portable oxygen concentrator (W-R1(MAX))
K250625 · Nanjing Yinuoji Medical Technology Co., Ltd. · Aug 2025
Portable Oxygen Concentrator (JM-P50A)
K251130 · Jiangsu Jumao X-Care Medical Equipment Co., Ltd. · Aug 2025
Portable Oxygen Concentrator (Spirit-3)
K242736 · Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. · Jun 2025
Portable Oxygen Concentrator (P2-TOC)
K242718 · Qingdao Kingon Medical Science and Technology Co., Ltd. · Feb 2025
Rugged Oxygen Generator (ROG) (RO01-00001)
K240561 · Molecular Products , Ltd. · Dec 2024