Cleared Traditional

K973981 - SAFEPASS STERILIZATION POUCH

K973981 is an FDA 510(k) clearance for SAFEPASS STERILIZATION POUCH, manufactured by Adroit Medical Systems, Inc.. The device is a Class 2 General Hospital device with product code KCT cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K973981 · Adroit Medical Systems, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1998
Decision
101d
Days
Class 2
Risk

K973981 is an FDA 510(k) clearance for the SAFEPASS STERILIZATION POUCH. Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by Adroit Medical Systems, Inc. (Loudon, US). The FDA issued a Cleared decision on January 29, 1998 after a review of 101 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6850 - 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 Adroit Medical Systems, Inc. devices

FDA 510(k) Submission Details - K973981

510(k) Number K973981 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 1997
Decision Date January 29, 1998
Days to Decision 101 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
28d faster than avg
Panel avg: 129d · This submission: 101d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KCT Device Classification - Class 2, Special Controls

Product Code KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6850
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 - KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

All 186
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K973981.
CLARICEL STERILIZATION POUCHES AND STERILIZATION REELS
K972719 · Medicel, S.A. DE C.V. · Feb 1999
C/T MED-SYSTEMS CASSETTE SYSTEM
K980065 · C/T Med System, Ltd. · May 1998
KIMBERLY-CLARK SELF-SEAL POUCH FOR LOW TEMPERATURE STERILIZATION
K973827 · Kimberly-Clark Corp. · Feb 1998
REXAM FRACTURE RESISTANT POUCH
K973440 · Rexam Medical Packaging, Inc. · Oct 1997
RE-BAG MULTI-USE POUCH, LARGE & SMALL
K954185 · Miltex, Inc. · Dec 1995
AUTO SUTURE* STERILIZATION TRAY**
K954090 · United States Surgical, A Division of Tyco Healthc · Nov 1995