Cleared Traditional

K014174 - HARVEY PV DRY STERILIZER, MODEL # ST127325

Also marketed or referenced as:
ST127320 ST127320-33

K014174 is an FDA 510(k) clearance for HARVEY PV DRY STERILIZER, manufactured by Barnstead/Thermolyne Corp.. The device is a Class 2 General Hospital device with product code FLE cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K014174 · Barnstead/Thermolyne Corp. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2002
Decision
64d
Days
Class 2
Risk

K014174 is an FDA 510(k) clearance for the HARVEY PV DRY STERILIZER, MODEL # ST127325. Classified as Sterilizer, Steam (product code FLE), Class II - Special Controls.

Submitted by Barnstead/Thermolyne Corp. (Dubuque, US). The FDA issued a Cleared decision on February 22, 2002 after a review of 64 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.

FDA 510(k) Submission Details - K014174

510(k) Number K014174 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2001
Decision Date February 22, 2002
Days to Decision 64 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 129d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Tuv Rheinland of North America, Inc.
REINER KRUMME

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FLE Sterilizer, Steam

All 171
Devices cleared under the same product code (FLE) and FDA review panel - the closest regulatory comparables to K014174.
BELIMED STEAM STERILIZER, MODEL TOP 5000
K021223 · Sauter AG · Jun 2002
AMSCO CENTURY MEDIUM STERILIZER 26 X 26
K020747 · STERIS Corporation · May 2002
MODEL 733HC GRAVITY/VACUUM STEAM STERILIZER
K020590 · Getinge/Castle, Inc. · Mar 2002
CASTLE 400HC/500HC SERIES STEAM STERILIZER, MODELS 422HC, 433HC, 522HC, AND 533HC
K012573 · Getinge/Castle, Inc. · Sep 2001
AMSCO CENTURY MEDIUM STERILIZER, MODEL CENTURY
K010865 · STERIS Corporation · May 2001
EHS SERIES TABLE TOP AUTOCLAVE, MODELS 2540 AND 3870
K003470 · Tuttnauer Co. , Ltd. · Feb 2001

FDA 510(k) Resources - General Hospital

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

K014174 · HARVEY PV DRY STERILIZER, MODEL # ST127325
Download PDF FDA Summary Barnstead/Thermolyne …