Cleared Traditional

K993268 - MALLINCKRODT DAR HEATED WIRE BREATHING CIRCUIT

K993268 is an FDA 510(k) clearance for MALLINCKRODT DAR HEATED WIRE BREATHING ..., manufactured by Mallinckrodt Dar S.R.L.. The device is a Class 2 Anesthesiology device with product code BTT cleared through the Traditional 510(k) pathway after a 202-day FDA review.

K993268 · Mallinckrodt Dar S.R.L. · Anesthesiology device
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Optimized for regulatory review, auditing and printing
Apr 2000
Decision
202d
Days
Class 2
Risk

K993268 is an FDA 510(k) clearance for the MALLINCKRODT DAR HEATED WIRE BREATHING CIRCUIT. Classified as Humidifier, Respiratory Gas, (direct Patient Interface) (product code BTT), Class II - Special Controls.

Submitted by Mallinckrodt Dar S.R.L. (Mirandola (Modena), IT). The FDA issued a Cleared decision on April 19, 2000 after a review of 202 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5450 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Mallinckrodt Dar S.R.L. devices

FDA 510(k) Submission Details - K993268

510(k) Number K993268 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1999
Decision Date April 19, 2000
Days to Decision 202 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d slower than avg
Panel avg: 140d · This submission: 202d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTT Device Classification - Class 2, Special Controls

Product Code BTT Humidifier, Respiratory Gas, (direct Patient Interface)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5450
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 - BTT Humidifier, Respiratory Gas, (direct Patient Interface)

All 148
Devices cleared under the same product code (BTT) and FDA review panel - the closest regulatory comparables to K993268.
HUMID-HEAT
K993773 · Hudson Rcj AB · Sep 2000
HUDSON RCI CONCHA COLUMN, CAT. NO. 385-40 AND HUDSON RCI CIRCUIT, CAT. NO. 780-40, 780-41, 780-42, 780-43
K993355 · Hudson Respiratory Care, Inc. · May 2000
HME-BOOSTER
K990614 · King Systems Corp. · May 2000
CLOUD 1 HUMIDIFICATION SYSTEM
K983862 · Respiratory Support Products, Inc. · May 1999
AIRLIFE BUBBLE HUMIDIFER, MODEL 002003 AND 002006
K991484 · Allegiance Healthcare Corp. · May 1999
RESPIRATORY HUMIDIFIER, MODEL # MR850
K983112 · Fisher &Paykel Healthcare , Ltd. · Nov 1998