Cleared Traditional

K921852 - 4 SURE TM RECTAL TUBE (FDA 510(k) Clearance)

Class I General Hospital device.

K921852 · Boston Pacific Medical, Inc. · General Hospital
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Oct 1993
Decision
539d
Days
Class 1
Risk

K921852 is an FDA 510(k) clearance for the 4 SURE TM RECTAL TUBE. Classified as Binder, Elastic (product code KMO), Class I - General Controls.

Submitted by Boston Pacific Medical, Inc. (Boston, US). The FDA issued a Cleared decision on October 8, 1993 after a review of 539 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5160 - the FDA general hospital 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 General Hospital submissions.

View all Boston Pacific Medical, Inc. devices

Submission Details

510(k) Number K921852 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1992
Decision Date October 08, 1993
Days to Decision 539 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
411d slower than avg
Panel avg: 128d · This submission: 539d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KMO Binder, Elastic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5160
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.