Cleared Traditional

STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R) (K181993) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K181993 · Sturdy Industrial Co., Ltd. · General Hospital
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Nov 2019
Decision
463d
Days
Class 2
Risk

K181993 is an FDA 510(k) clearance for the STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R). Classified as Sterilizer, Steam (product code FLE), Class II - Special Controls.

Submitted by Sturdy Industrial Co., Ltd. (New Taipei City, TW). The FDA issued a Cleared decision on November 1, 2019 after a review of 463 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Sturdy Industrial Co., Ltd. devices

Submission Details

510(k) Number K181993 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 2018
Decision Date November 01, 2019
Days to Decision 463 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
334d slower than avg
Panel avg: 129d · This submission: 463d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 61
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K191896 · Belimed AG · Oct 2019
STATCLAVE G4 Chamber Autoclave
K190062 · Scican , Ltd. · Jul 2019
Tuttnauer Horizontal Models:4472,5596,6690,66120,69120 and 69180 autoclaves
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