Cleared Traditional

K972899 - CYPRESS MEDICAL PRODUCTS ANEROID SPHYGM...

K972899 is an FDA 510(k) clearance for CYPRESS MEDICAL PRODUCTS ANEROID SPHYGM..., manufactured by Cypress Medical Products, Ltd.. The device is a Class 2 Cardiovascular device with product code DXQ cleared through the Traditional 510(k) pathway after a 335-day FDA review.

K972899 · Cypress Medical Products, Ltd. · Cardiovascular device
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Jul 1998
Decision
335d
Days
Class 2
Risk

K972899 is an FDA 510(k) clearance for the CYPRESS MEDICAL PRODUCTS ANEROID SPHYGMOMANOMETER. Classified as Blood Pressure Cuff (product code DXQ), Class II - Special Controls.

Submitted by Cypress Medical Products, Ltd. (Mc Henry, US). The FDA issued a Cleared decision on July 7, 1998 after a review of 335 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Cypress Medical Products, Ltd. devices

FDA 510(k) Submission Details - K972899

510(k) Number K972899 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 1997
Decision Date July 07, 1998
Days to Decision 335 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
210d slower than avg
Panel avg: 125d · This submission: 335d
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 K972899.
CLEEN-ABLE
K994044 · Vital Signs, Inc. · Feb 2000
CUFF-ABLE PLUS
K990412 · Vital Signs, Inc. · Sep 1999
DEROYAL STERILE NEONATAL BLOOD PRESSURE CUFF
K991525 · Deroyal Industries, Inc. · Jul 1999
CRITIKON SOFT BLOOD PRESSURE CUFF
K974080 · Johnson & Johnson Medical, Inc. · May 1998
RI-MEGA
K972377 · Rudolf Riester GmbH & Co. KG · Sep 1997
SANAPHON N
K972378 · Rudolf Riester GmbH & Co. KG · Sep 1997