Cleared Traditional

K970907 - CASTLE SERIES 100 STEAM STERILIZERS (STRAIGHTLINE)

K970907 is an FDA 510(k) clearance for CASTLE SERIES 100 STEAM STERILIZERS (ST..., manufactured by Getinge/Castle, Inc.. The device is a Class 2 General Hospital device with product code FLE cleared through the Traditional 510(k) pathway after a 246-day FDA review.

K970907 · Getinge/Castle, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1997
Decision
246d
Days
Class 2
Risk

K970907 is an FDA 510(k) clearance for the CASTLE SERIES 100 STEAM STERILIZERS (STRAIGHTLINE). Classified as Sterilizer, Steam (product code FLE), Class II - Special Controls.

Submitted by Getinge/Castle, Inc. (Rochester, US). The FDA issued a Cleared decision on November 12, 1997 after a review of 246 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 Getinge/Castle, Inc. devices

FDA 510(k) Submission Details - K970907

510(k) Number K970907 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1997
Decision Date November 12, 1997
Days to Decision 246 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
117d slower than avg
Panel avg: 129d · This submission: 246d
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

Met Laboratories, Inc.
DONALD R HAMILTON

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 90
Devices cleared under the same product code (FLE) and FDA review panel - the closest regulatory comparables to K970907.
EAGLE CENTURY STEAM STERILIZER
K964332 · Amsco Intl., Inc. · Jun 1998
THE SYSTEM 2S STEAM STERILIZER
K980014 · STERIS Corporation · May 1998
CASTLE SERIES 200 STEAM STERILIZER (POWERCLAVE)
K973225 · Getinge/Castle, Inc. · Feb 1998
TUTTNAUER TABLE-TOP AUTOCLAVE
K973550 · Tuttnauer U.S.A Co, Ltd. · Oct 1997
STERRADD STERILIZATION SYSTEM
K954142 · Advanced Sterilization Products · Jun 1997
STRYKER ENCORE STERILIZER
K962755 · Stryker Corp. · Mar 1997

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.