Cleared Special

K011789 - PROCEDURE MASKS: PM4-301 AND PM4-304

K011789 is an FDA 510(k) clearance for PROCEDURE MASKS: PM4-301 AND PM4-304, manufactured by Primeline Medical Products, Inc.. The device is a Class 2 General Hospital device with product code FXX cleared through the Special 510(k) pathway after a 14-day FDA review.

K011789 · Primeline Medical Products, Inc. · General Hospital
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Jun 2001
Decision
14d
Days
Class 2
Risk

K011789 is an FDA 510(k) clearance for the PROCEDURE MASKS: PM4-301 AND PM4-304. 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 June 22, 2001 after a review of 14 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K011789

510(k) Number K011789 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 2001
Decision Date June 22, 2001
Days to Decision 14 days
Submission Type Special
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
115d faster than avg
Panel avg: 129d · This submission: 14d
Pathway characteristics
Modification to existing cleared device.

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 K011789.
DERMASSIST FLUID RESISTANT SURGICAL MASK WITH WRAPAROUND VISOR
K021546 · Creative Contract (M) Sdn Bhd · Mar 2003
PRIMAGARD YELLOW SURGICAL MASK, PLEATED, TIE-ON, PM4-307
K021076 · Primeline Medical Products, Inc. · Apr 2002
CROSSTEX ISOLITE EARLOOP FACE MASKS-BLUE, PINK, CROSSTEX ISOFLUID EARLOOP FACE MASKS-BLUE, PINK, WHITE, GREEN. CROSSTEX
K012602 · Crosstex Intl. · Jan 2002
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
K011789 · PROCEDURE MASKS: PM4-301 AND PM4-304
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