Cleared Traditional

K001951 - PRIMED PLEATED TIE-BACK, PROCEDURE MASK PM4-305, PRIMED PLEATED EAR-LOOP, PROCEDURE MASK PM4-306

K001951 is an FDA 510(k) clearance for PRIMED PLEATED TIE-BACK, manufactured by Primeline Medical Products, Inc.. The device is a Class 2 General Hospital device with product code FXX cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K001951 · Primeline Medical Products, Inc. · General Hospital
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Sep 2000
Decision
73d
Days
Class 2
Risk

K001951 is an FDA 510(k) clearance for the PRIMED PLEATED TIE-BACK, PROCEDURE MASK PM4-305, PRIMED PLEATED EAR-LOOP, PRO.... Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Primeline Medical Products, Inc. (Edmonton, Alberta, CA). The FDA issued a Cleared decision on September 8, 2000 after a review of 73 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K001951

510(k) Number K001951 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2000
Decision Date September 08, 2000
Days to Decision 73 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 129d · This submission: 73d
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 564
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K001951.
WHITE KNIGHT MASKS (21 MODELS, VARIOUS COLORS WITH AND WITHOUT FACE SHIELDS)
K001892 · White Knight Healthcare, Inc. · Apr 2001
WHITE KNIGHT MASKS, BLUE, PINK, YELLOW, WHITE MASKS (13 MODELS)
K001893 · White Knight Healthcare, Inc. · Apr 2001
WHITE KNIGHT BLUE, GREEN FACE MASK, (4 MODELS)
K001997 · White Knight Healthcare, Inc. · Apr 2001
HENRY SCHEIN SURGICAL MASK
K992604 · Mitsui Textile Corp. · Jan 2000
MEDLINE PROHIBIT SERIES SURGICAL MASK WITH FLUID SHIELD
K991559 · Medline Industries, Inc. · Aug 1999
EARLOOP FACE MASK
K990719 · Shuenn Bao Shing Corp. · Jul 1999
K001951 · PRIMED PLEATED TIE-BACK, PROCEDURE MASK PM4-305, PRIMED PLEATED EAR-LOOP, PROCEDURE MASK PM4-306
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