Cleared Traditional

K990412 - CUFF-ABLE PLUS

K990412 is the FDA 510(k) clearance for CUFF-ABLE PLUS by Vital Signs, Inc.. It is a Class 2 Cardiovascular device (product code DXQ) cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K990412 · Vital Signs, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1999
Decision
203d
Days
Class 2
Risk

K990412 is an FDA 510(k) clearance for the CUFF-ABLE PLUS. Classified as Blood Pressure Cuff (product code DXQ), Class II - Special Controls.

Submitted by Vital Signs, Inc. (Totowa, US). The FDA issued a Cleared decision on September 1, 1999 after a review of 203 days - an extended review cycle.

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. 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 Vital Signs, Inc. devices

Submission Details

510(k) Number K990412 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 1999
Decision Date September 01, 1999
Days to Decision 203 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
78d slower than avg
Panel avg: 125d · This submission: 203d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 86
Devices cleared under the same product code (DXQ) and FDA review panel - the closest regulatory comparables to K990412.
EMPIRE N BLOOD PRESSURE MANOMETERS
K002955 · Rudolf Riester GmbH & Co. KG · Dec 2000
OSCILLOMITT, MODELS CM 1050, CM 1040, CM 1030, CM 1020, CM 1010
K000512 · Cas Medical Systems, Inc. · Sep 2000
CLEEN-ABLE
K994044 · Vital Signs, Inc. · Feb 2000
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