Cleared Traditional

K974180 - STERI-TAMP

K974180 is an FDA 510(k) clearance for STERI-TAMP, manufactured by Pharmacy, Inc.. The device is a Class 2 General Hospital device with product code KPE cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K974180 · Pharmacy, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1998
Decision
110d
Days
Class 2
Risk

K974180 is an FDA 510(k) clearance for the STERI-TAMP. Classified as Container, I.v. (product code KPE), Class II - Special Controls.

Submitted by Pharmacy, Inc. (New Port Riche, US). The FDA issued a Cleared decision on February 24, 1998 after a review of 110 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5025 - 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 Pharmacy, Inc. devices

FDA 510(k) Submission Details - K974180

510(k) Number K974180 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 1997
Decision Date February 24, 1998
Days to Decision 110 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
19d faster than avg
Panel avg: 129d · This submission: 110d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPE Device Classification - Class 2, Special Controls

Product Code KPE Container, I.v.
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5025
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 - KPE Container, I.v.

All 53
Devices cleared under the same product code (KPE) and FDA review panel - the closest regulatory comparables to K974180.
ALL-IN-ONE TWO CHAMBER CONTAINER 3200 ML, 2000 ML & 1000 ML
K020485 · Baxter Healthcare Corp · Mar 2002
ALL-IN-ONE CONTAINER CAT#'S 2B8114,2B8124, 2B8134, 2B8144, 2B8102, 2B8152, 2B8112, 2B8117M 2B8122, 2B8132, 2B8142, 2B712
K983294 · Baxter Healthcare Corp · Nov 1998
MPS RESERVOIR BAG
K982048 · Medical Product Specialists · Jul 1998
CHARTERMED TPN-EVA BAGS
K973103 · Chartermed, Inc. · Nov 1997
VITALMIX PLUS EMPTY I.V. CONTAINER
K972464 · Pacific Device, Inc. · Nov 1997
INTRAVIA CONTAINER, EMPTY
K964853 · Baxter Healthcare Corp · Mar 1997