Cleared Traditional

K170304 - Astell UMB 220, UMB 230, UMB 240 Autoclaves/sterilizers (FDA 510(k) Clearance)

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

K170304 · Astell Scientific Limited · General Hospital
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Mar 2018
Decision
395d
Days
Class 2
Risk

K170304 is an FDA 510(k) clearance for the Astell UMB 220, UMB 230, UMB 240 Autoclaves/sterilizers. Classified as Sterilizer, Steam (product code FLE), Class II - Special Controls.

Submitted by Astell Scientific Limited (Sidcup, GB). The FDA issued a Cleared decision on March 2, 2018 after a review of 395 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Astell Scientific Limited devices

Submission Details

510(k) Number K170304 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 2017
Decision Date March 02, 2018
Days to Decision 395 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
267d slower than avg
Panel avg: 128d · This submission: 395d
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 183
Devices cleared under the same product code (FLE) and FDA review panel - the closest regulatory comparables to K170304.
Enbio PRO
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