Cleared Traditional

K972849 - ISOSAFE EARLOOP PROCEDURE MASK (BLUE

K972849 is an FDA 510(k) clearance for ISOSAFE EARLOOP PROCEDURE MASK (BLUE, manufactured by Cypress Medical Products, Ltd.. The device is a Class 2 General Hospital device with product code FXX cleared through the Traditional 510(k) pathway after a 300-day FDA review.

K972849 · Cypress Medical Products, Ltd. · General Hospital
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May 1998
Decision
300d
Days
Class 2
Risk

K972849 is an FDA 510(k) clearance for the ISOSAFE EARLOOP PROCEDURE MASK (BLUE, YELLOW). Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Cypress Medical Products, Ltd. (Mc Henry, US). The FDA issued a Cleared decision on May 28, 1998 after a review of 300 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4040 - the FDA general hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Cypress Medical Products, Ltd. devices

FDA 510(k) Submission Details - K972849

510(k) Number K972849 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1997
Decision Date May 28, 1998
Days to Decision 300 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
171d slower than avg
Panel avg: 129d · This submission: 300d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FXX Device Classification - Class 2, Special Controls

Product Code FXX Mask, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4040
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 General Hospital devices follow this clearance model.

Regulatory Peers - FXX Mask, Surgical

All 439
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K972849.
KC 300 SURGICAL MASK
K131879 · Kimberly-Clark Corp. · Dec 2013
KIMBERLY-CLARK LOW BARRIER, ASTM 2100 FACE MASKS
K110455 · Kimberly-Clark Corp. · Apr 2011
MEDLINE PROHIBIT SERIES SURGICAL MASK WITH FLUID SHIELD
K991559 · Medline Industries, Inc. · Aug 1999
DEPUY OPTI-CON AND E-Z SHIELD SYSTEMS
K964114 · Depuy, Inc. · May 1997
MEDLINE ADMISSION KITS
K965107 · Medline Industries, Inc. · Mar 1997
PROCEDURE SPECIFIC KITS
K964168 · Sage Products, Inc. · Mar 1997