Cleared Traditional

K981643 - RTM DVT PROSOFT CUFF MODEL NUMBER PS100

K981643 is an FDA 510(k) clearance for RTM DVT PROSOFT CUFF MODEL NUMBER PS100, manufactured by R.T. Medical Services, Inc.. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Traditional 510(k) pathway after a 220-day FDA review.

K981643 · R.T. Medical Services, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1998
Decision
220d
Days
Class 2
Risk

K981643 is an FDA 510(k) clearance for the RTM DVT PROSOFT CUFF MODEL NUMBER PS100. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by R.T. Medical Services, Inc. (Akron, US). The FDA issued a Cleared decision on December 14, 1998 after a review of 220 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5800 - the FDA cardiovascular device oversight 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all R.T. Medical Services, Inc. devices

FDA 510(k) Submission Details - K981643

510(k) Number K981643 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 1998
Decision Date December 14, 1998
Days to Decision 220 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
95d slower than avg
Panel avg: 125d · This submission: 220d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOW Device Classification - Class 2, Special Controls

Product Code JOW Sleeve, Limb, Compressible
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5800
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - JOW Sleeve, Limb, Compressible

All 153
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K981643.
TRINITY II SINGLE CHAMBER DVT PUMP
K983680 · Delphi Consulting Group · Apr 1999
COWBOY XV
K981311 · Kci New Technologies, Inc. · Apr 1999
VASO PRESS SYSTEM
K974393 · Britt Corp., Inc. · Mar 1999
D903 AVANT ADULT HOLLOW FIBER OXYGENATOR
K980600 · Dideco S.P.A. · Aug 1998
BIOMEDICAL HORIZONS INC. COMPRESSION PUMP, MODEL 651
K971892 · Biomedical Horizons, Inc. · Aug 1998
JOBST ATHROMBIC PUMP SYSTEM 2600
K980456 · Jobst A Beiersdorf Co. · May 1998