Cleared Traditional

K934180 - SLIMLINE 3000

K934180 is an FDA 510(k) clearance for SLIMLINE 3000, manufactured by Pymah Corp.. The device is a Class 2 Cardiovascular device with product code DXQ cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K934180 · Pymah Corp. · Cardiovascular device
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Nov 1993
Decision
89d
Days
Class 2
Risk

K934180 is an FDA 510(k) clearance for the SLIMLINE 3000. Classified as Blood Pressure Cuff (product code DXQ), Class II - Special Controls.

Submitted by Pymah Corp. (Potomac, US). The FDA issued a Cleared decision on November 24, 1993 after a review of 89 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Pymah Corp. devices

FDA 510(k) Submission Details - K934180

510(k) Number K934180 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 1993
Decision Date November 24, 1993
Days to Decision 89 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
36d faster than avg
Panel avg: 125d · This submission: 89d
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 134
Devices cleared under the same product code (DXQ) and FDA review panel - the closest regulatory comparables to K934180.
MINIMUS II
K942777 · Rudolf Riester GmbH & Co. KG · Jul 1994
HAND ANEROID SPHYGMOMANOMETER
K940493 · Welch Allyn, Inc. · Jul 1994
RI-MED
K925297 · Rudolf Riester GmbH & Co. KG · Jan 1994
DISPOSABLE PENILE BLOOD PRESSURE CUFFS
K932851 · D. E. Hokanson, Inc. · Nov 1993
TEMPA-KUFF SINGLE PAT PRE-GAGED BALANCED DISP CUFF
K925744 · Pymah Corp. · Jul 1993
BALANCED(TM) NYLON BLADDER
K930604 · Pymah Corp. · Apr 1993