Cleared Traditional

K885216 - ATTACHABLE LANZ (TENTATIVE)

K885216 is an FDA 510(k) clearance for ATTACHABLE LANZ (TENTATIVE), manufactured by Mallinckroot, Inc.. The device is a Class 2 Anesthesiology device with product code BSK cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K885216 · Mallinckroot, Inc. · Anesthesiology device
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Mar 1989
Decision
85d
Days
Class 2
Risk

K885216 is an FDA 510(k) clearance for the ATTACHABLE LANZ (TENTATIVE). Classified as Cuff, Tracheal Tube, Inflatable (product code BSK), Class II - Special Controls.

Submitted by Mallinckroot, Inc. (Argyle, US). The FDA issued a Cleared decision on March 14, 1989 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5750 - 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: 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 Mallinckroot, Inc. devices

FDA 510(k) Submission Details - K885216

510(k) Number K885216 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 1988
Decision Date March 14, 1989
Days to Decision 85 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 140d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BSK Device Classification - Class 2, Special Controls

Product Code BSK Cuff, Tracheal Tube, Inflatable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5750
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - BSK Cuff, Tracheal Tube, Inflatable

All 27
Devices cleared under the same product code (BSK) and FDA review panel - the closest regulatory comparables to K885216.
CUFF SENTRY
K102674 · Ventlab Corp. · Jul 2011
PILOT TUBE REPAIR KIT
K973755 · Instrumentation Industries, Inc. · Dec 1997
RUSCH ENDOTEST CUFF PRESSURE MONITOR
K951046 · Rusch Intl. · Apr 1995
BE 410 ENDOTRACHEAL TUBE/TRACH TUBE, PILOT REPAIR
K884638 · Instrumentation Industries, Inc. · Nov 1988
CUFFCHECK
K881178 · Dhd Medical Products Div. Diemolding Corp. · Apr 1988
RESPIRONICS PR VALVE
K833327 · Respironics, Inc. · Nov 1983