Cleared Traditional

K250671 - FreeStyle Comfort (AS200 / FreeStyle Co...

K250671 is an FDA 510(k) clearance for FreeStyle Comfort (AS200 / FreeStyle Co..., manufactured by Caire, Inc.. The device is a Class 2 Anesthesiology device with product code CAW cleared through the Traditional 510(k) pathway after a 128-day FDA review.

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

FDA 510(k) Submission Details - K250671

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.

CAW Device Classification - Class 2, Special Controls

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 91
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