Cleared Traditional

ULTRASOUND TRANSDUCER DRAPE (K970893) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K970893 · Protek Medical Products, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1997
Decision
223d
Days
Class 2
Risk

K970893 is an FDA 510(k) clearance for the ULTRASOUND TRANSDUCER DRAPE. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Protek Medical Products, Inc. (Iowa City, US). The FDA issued a Cleared decision on October 20, 1997 after a review of 223 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4040 - 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 Protek Medical Products, Inc. devices

Submission Details

510(k) Number K970893 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1997
Decision Date October 20, 1997
Days to Decision 223 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d slower than avg
Panel avg: 129d · This submission: 223d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FYA Gown, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4040
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 - FYA Gown, Surgical

All 104
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K970893.
MEDLINE MEDCREST SURGICAL GOWNS AND SURGICAL DRAPES
K982694 · Medline Industries, Inc. · Dec 1998
MEDINE DISPOSABLE STERILE ZONED IMPERVIOUS SURGICAL GOWNS
K982693 · Medline Industries, Inc. · Oct 1998
PROVISION SURGICAL HELMET SYSTEM
K972832 · Depuy, Inc. · Oct 1997
CONVERTORS POLYOLEFIN FABRIC GOWNS
K961341 · Baxter Healthcare Corp · Oct 1996
DEPUY STERILE VIEW BARRIER HOOD/GOWN WITH HYTREL
K961239 · Depuy, Inc. · Sep 1996
INTERWOVEN(TM) REUSABLE SURGICAL GOWN
K945658 · Baxter Healthcare Corp · Mar 1995