Cleared Traditional

K771229 - STERILIZERS, 3100 SERIES TRIM LINE

K771229 is an FDA 510(k) clearance for STERILIZERS, manufactured by Castle Co.. The device is a Class 2 General Hospital device with product code FLE cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K771229 · Castle Co. · General Hospital
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Aug 1977
Decision
26d
Days
Class 2
Risk

K771229 is an FDA 510(k) clearance for the STERILIZERS, 3100 SERIES TRIM LINE. Classified as Sterilizer, Steam (product code FLE), Class II - Special Controls.

Submitted by Castle Co. (Mchenry, US). The FDA issued a Cleared decision on August 2, 1977 after a review of 26 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6880 - 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.

View all Castle Co. devices

FDA 510(k) Submission Details - K771229

510(k) Number K771229 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 1977
Decision Date August 02, 1977
Days to Decision 26 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
103d faster than avg
Panel avg: 129d · This submission: 26d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FLE Device Classification - Class 2, Special Controls

Product Code FLE Sterilizer, Steam
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6880
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 - FLE Sterilizer, Steam

All 149
Devices cleared under the same product code (FLE) and FDA review panel - the closest regulatory comparables to K771229.
RITTER STERILIZER
K801309 · Sybron Corp. · Jun 1980
STERILIZING CASE CAT. NO. 65199
K800080 · Edward Weck, Inc. · Jan 1980
STERILIZER, EAGLE 2000
K781684 · American Sterilizer Co. · Oct 1978
STERILIZER, SERIES 3000, MODIFICATION TO
K770682 · Castle Co. · May 1977
STEAM STERILIZER, 3000
K770536 · Castle Co. · Apr 1977
STERILIZER, STEAM, CASTLE 3000
K770372 · Castle Co. · Apr 1977