Cleared Traditional

K820052 - SAFETY PINS

K820052 · Stan-Pak Ent. · General & Plastic Surgery device
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Feb 1982
Decision
24d
Days
-
Risk

K820052 is an FDA 510(k) clearance for the SAFETY PINS.

Submitted by Stan-Pak Ent. (Mchenry, US). The FDA issued a Cleared decision on February 4, 1982 after a review of 24 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. 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 Stan-Pak Ent. devices

FDA 510(k) Submission Details - K820052

510(k) Number K820052 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 1982
Decision Date February 04, 1982
Days to Decision 24 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
91d faster than avg
Panel avg: 115d · This submission: 24d
Pathway characteristics
Predicate-based equivalence.

LDQ Device Classification - Class ,

Product Code LDQ
Device Class -

Regulatory Peers - LDQ

All 39
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TRACHEOSTOMY CARE TRAY
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POSTURE MIRROR
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K812482 · Maddak, Inc. · Sep 1981