Cleared Traditional

K843058 - Q-DOP

K843058 is an FDA 510(k) clearance for Q-DOP, manufactured by Quinton, Inc.. The device is a Class 2 Cardiovascular device with product code JOP cleared through the Traditional 510(k) pathway after a 250-day FDA review.

K843058 · Quinton, Inc. · Cardiovascular device
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Apr 1985
Decision
250d
Days
Class 2
Risk

K843058 is an FDA 510(k) clearance for the Q-DOP. Classified as Transducer, Ultrasonic (product code JOP), Class II - Special Controls.

Submitted by Quinton, Inc. (Seattle, US). The FDA issued a Cleared decision on April 10, 1985 after a review of 250 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2880 - 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 Quinton, Inc. devices

FDA 510(k) Submission Details - K843058

510(k) Number K843058 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 1984
Decision Date April 10, 1985
Days to Decision 250 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
125d slower than avg
Panel avg: 125d · This submission: 250d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOP Device Classification - Class 2, Special Controls

Product Code JOP Transducer, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2880
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 - JOP Transducer, Ultrasonic

All 54
Devices cleared under the same product code (JOP) and FDA review panel - the closest regulatory comparables to K843058.
MILLAR MIKRO-TIP DOPPLER CATHETER
K853138 · Millar Instruments, Inc. · Oct 1985
DOPLETTE 10
K851269 · Imex Medical Systems, Inc. · Jul 1985
3.5. MHZ PROBE FOR AUSONICS 150 & 357 REAL TIME CA
K851616 · Ausonics Pty , Ltd. · Jul 1985
CARDIAC SECTOR PROBE 3.5. MHZ
K850145 · Siemens Medical Solutions USA, Inc. · Apr 1985
CARDIAC SECTOR PROBE 5.0 MHZ
K850216 · Siemens Medical Solutions USA, Inc. · Apr 1985
SCANHEADS-ACCESS 10PV, BIOSTATIC
K843620 · Advanced Technology Laboratories, Inc. · Mar 1985