Cleared Traditional

K170304 - Astell UMB 220

K170304 is an FDA 510(k) clearance for Astell UMB 220, manufactured by Astell Scientific Limited. The device is a Class 2 General Hospital device with product code FLE cleared through the Traditional 510(k) pathway after a 395-day FDA review.

K170304 · Astell Scientific Limited · General Hospital
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Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K170304

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
266d slower than avg
Panel avg: 129d · This submission: 395d
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 84
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