Cleared Traditional

K895422 - TOWER SELF SEAL STERILIZATION POUCH

K895422 is the FDA 510(k) clearance for TOWER SELF SEAL STERILIZATION POUCH by Baxter Healthcare Corp. It is a Class 2 General Hospital device (product code JOJ) cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K895422 · Baxter Healthcare Corp · General Hospital
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Nov 1989
Decision
89d
Days
Class 2
Risk

K895422 is an FDA 510(k) clearance for the TOWER SELF SEAL STERILIZATION POUCH. Classified as Indicator, Physical/chemical Sterilization Process (product code JOJ), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Deerfield Lake, US). The FDA issued a Cleared decision on November 29, 1989 after a review of 89 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2800 - 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.

View all Baxter Healthcare Corp devices

Submission Details

510(k) Number K895422 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 1989
Decision Date November 29, 1989
Days to Decision 89 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 129d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JOJ Indicator, Physical/chemical Sterilization Process
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.2800
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 - JOJ Indicator, Physical/chemical Sterilization Process

All 115
Devices cleared under the same product code (JOJ) and FDA review panel - the closest regulatory comparables to K895422.
STERRAD CHEMICAL INDICATOR
K921910 · Johnson & Johnson Medical, Inc. · Oct 1993
CHEMDI-VHP CHEMICAL INDICATOR
K922485 · American Sterilizer Co. · Sep 1993
BOWIE-DICK TEST CARD CATALOG NUMBER 008018
K897045 · Edward Weck, Inc. · Feb 1990
DART DAILY AIR REMOVAL TEST
K844512 · American Sterilizer Co. · Mar 1985
STERILIZATION PROCESS INDICATOR
K841168 · Parke-Davis Co. · May 1984
CHEMDI STEAM & GAS STERILIZATION INDICA
K823074 · American Sterilizer Co. · Nov 1982