Cleared Traditional

K800511 - SHIELD LUCKY CAP

Also marketed or referenced as:
BLOSSOM BOUFFANT CAP

K800511 is an FDA 510(k) clearance for SHIELD LUCKY CAP, manufactured by American Convertors Div., American Pharmaseal. The device is a Class 1 General & Plastic Surgery device with product code FYF cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K800511 · American Convertors Div., American Pharmaseal · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1980
Decision
42d
Days
Class 1
Risk

K800511 is an FDA 510(k) clearance for the SHIELD LUCKY CAP. Classified as Cap, Surgical (product code FYF), Class I - General Controls.

Submitted by American Convertors Div., American Pharmaseal (Mchenry, US). The FDA issued a Cleared decision on April 16, 1980 after a review of 42 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4040 - the FDA general and plastic surgery 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.

View all American Convertors Div., American Pharmaseal devices

FDA 510(k) Submission Details - K800511

510(k) Number K800511 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 1980
Decision Date April 16, 1980
Days to Decision 42 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 115d · This submission: 42d
Pathway characteristics
Predicate-based equivalence.

FYF Device Classification - Class 1, General Controls

Product Code FYF Cap, Surgical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4040
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - FYF Cap, Surgical

All 18
Devices cleared under the same product code (FYF) and FDA review panel - the closest regulatory comparables to K800511.
BOUNDARY HEADWEAR
K831357 · Procter & Gamble Mfg. Co. · Jun 1983
DISPOSABLE SURGERY CAPS & HOODS
K810199 · Anago, Inc. · Feb 1981
DISPOSABLE NURSES CAP
K802186 · Anago, Inc. · Sep 1980
CAP, CLARION NURSES, STYLE BOUFFANT 21
K770258 · Sherwood Medical Industries · Mar 1977
CAP, CLARION SURGEON'S
K770259 · Sherwood Medical Industries · Mar 1977
CAP, CLARION NURSES OR (TECHNIC)
K770260 · Sherwood Medical Industries · Mar 1977