Cleared Traditional

K921851 - 4 SURE TM SUCTION CATHETERS & KITS (FDA 510(k) Clearance)

Class I Anesthesiology device.

K921851 · Boston Pacific Medical, Inc. · Anesthesiology device
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Jul 1993
Decision
446d
Days
Class 1
Risk

K921851 is an FDA 510(k) clearance for the 4 SURE TM SUCTION CATHETERS & KITS. Classified as Catheters, Suction, Tracheobronchial (product code BSY), Class I - General Controls.

Submitted by Boston Pacific Medical, Inc. (Boston, US). The FDA issued a Cleared decision on July 7, 1993 after a review of 446 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.6810 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Boston Pacific Medical, Inc. devices

Submission Details

510(k) Number K921851 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received April 17, 1992
Decision Date July 07, 1993
Days to Decision 446 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
307d slower than avg
Panel avg: 139d · This submission: 446d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BSY Catheters, Suction, Tracheobronchial
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.6810
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.