Cleared Traditional

K881521 - MODIFIED SERVO SYRINGE

K881521 is an FDA 510(k) clearance for MODIFIED SERVO SYRINGE, manufactured by Engineering, Inc.. The device is a Class 2 Cardiovascular device with product code DXT cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K881521 · Engineering, Inc. · Cardiovascular device
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May 1988
Decision
53d
Days
Class 2
Risk

K881521 is an FDA 510(k) clearance for the MODIFIED SERVO SYRINGE. Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by Engineering, Inc. (Fort Lauderdale, US). The FDA issued a Cleared decision on May 31, 1988 after a review of 53 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1650 - 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 Engineering, Inc. devices

FDA 510(k) Submission Details - K881521

510(k) Number K881521 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1988
Decision Date May 31, 1988
Days to Decision 53 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 125d · This submission: 53d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXT Device Classification - Class 2, Special Controls

Product Code DXT Injector And Syringe, Angiographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1650
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 - DXT Injector And Syringe, Angiographic

All 172
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K881521.
MERIT INTELLIFLATOR(TM) & MERIT MONITOR(TM)
K884913 · Merit Medical Systems, Inc. · Apr 1989
ACS INDEFLATOR P/T 20
K883452 · Advanced Cardiovascular Systems, Inc. · Oct 1988
L-F COILED EXTENSION TUBING
K882329 · Mallinckrodt Group, Inc. · Sep 1988
INJECTOR HANDLE WITH SYRINGE
K880987 · Applied Vascular Devices, Inc. · May 1988
MEDRAD MICROPROCESSOR CT INJECTION SYSTEM
K880493 · Medrad, Inc. · Apr 1988
ANGIO DRAPE PACK ACP-010FM
K880310 · Arrow Intl., Inc. · Apr 1988