Cleared Traditional

K881825 - MODELS SP5825/SP5835/SP5845/SP5855 PERCU. SHEATH

K881825 is an FDA 510(k) clearance for MODELS SP5825/SP5835/SP5845/SP5855 PERC..., manufactured by Spectramed, Inc.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 152-day FDA review.

K881825 · Spectramed, Inc. · Cardiovascular device
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Sep 1988
Decision
152d
Days
Class 2
Risk

K881825 is an FDA 510(k) clearance for the MODELS SP5825/SP5835/SP5845/SP5855 PERCU. SHEATH. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Spectramed, Inc. (Oxnard, US). The FDA issued a Cleared decision on September 28, 1988 after a review of 152 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - 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 Spectramed, Inc. devices

FDA 510(k) Submission Details - K881825

510(k) Number K881825 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1988
Decision Date September 28, 1988
Days to Decision 152 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d slower than avg
Panel avg: 125d · This submission: 152d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DYB Device Classification - Class 2, Special Controls

Product Code DYB Introducer, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1340
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 - DYB Introducer, Catheter

All 615
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K881825.
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