Cleared Traditional

K925297 - RI-MED

K925297 is an FDA 510(k) clearance for RI-MED, manufactured by Rudolf Riester GmbH & Co. KG. The device is a Class 2 Cardiovascular device with product code DXQ cleared through the Traditional 510(k) pathway after a 450-day FDA review.

K925297 · Rudolf Riester GmbH & Co. KG · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1994
Decision
450d
Days
Class 2
Risk

K925297 is an FDA 510(k) clearance for the RI-MED. Classified as Blood Pressure Cuff (product code DXQ), Class II - Special Controls.

Submitted by Rudolf Riester GmbH & Co. KG (D-72417 Jungingen, DE). The FDA issued a Cleared decision on January 14, 1994 after a review of 450 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1120 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Rudolf Riester GmbH & Co. KG devices

FDA 510(k) Submission Details - K925297

510(k) Number K925297 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1992
Decision Date January 14, 1994
Days to Decision 450 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
325d slower than avg
Panel avg: 125d · This submission: 450d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXQ Device Classification - Class 2, Special Controls

Product Code DXQ Blood Pressure Cuff
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1120
Definition A Blood Pressure Cuff Is A Device That Has An Inflatable Bladder In An Elastic Sleeve (cuff) With A Mechanism For Inflating The Bladder. The Cuff Is Used To Determine A Subject's Blood Pressure.
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 - DXQ Blood Pressure Cuff

All 87
Devices cleared under the same product code (DXQ) and FDA review panel - the closest regulatory comparables to K925297.
DEROYAL INDUSTRIS, INC. BLOOD PRESSURE CUFF
K953952 · Deroyal Industries, Inc. · Sep 1995
MINIMUS II
K942777 · Rudolf Riester GmbH & Co. KG · Jul 1994
HAND ANEROID SPHYGMOMANOMETER
K940493 · Welch Allyn, Inc. · Jul 1994
BLOOD PRESSURE CUFFS
K912638 · Vital Signs, Inc. · Jul 1991
ADULT,STERILE,DISPOS.,NONIVAS.,BLOOD PRESS. CUFFS
K905147 · Hewlett-Packard Co. · Dec 1990
NEONATAL/STERILE/DISPOS/NONINVAS BLOOD PRESS CUFF
K905101 · Hewlett-Packard Co. · Dec 1990