Cleared Traditional

K993355 - HUDSON RCI CONCHA COLUMN, CAT. NO. 385-40 AND HUDSON RCI CIRCUIT, CAT. NO. 780-40, 780-41, 780-42, 780-43

K993355 is an FDA 510(k) clearance for HUDSON RCI CONCHA COLUMN, manufactured by Hudson Respiratory Care, Inc.. The device is a Class 2 Anesthesiology device with product code BTT cleared through the Traditional 510(k) pathway after a 231-day FDA review.

K993355 · Hudson Respiratory Care, Inc. · Anesthesiology device
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May 2000
Decision
231d
Days
Class 2
Risk

K993355 is an FDA 510(k) clearance for the HUDSON RCI CONCHA COLUMN, CAT. NO. 385-40 AND HUDSON RCI CIRCUIT, CAT. NO. 78.... Classified as Humidifier, Respiratory Gas, (direct Patient Interface) (product code BTT), Class II - Special Controls.

Submitted by Hudson Respiratory Care, Inc. (Temecula, US). The FDA issued a Cleared decision on May 24, 2000 after a review of 231 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.

FDA 510(k) Submission Details - K993355

510(k) Number K993355 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 1999
Decision Date May 24, 2000
Days to Decision 231 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
91d slower than avg
Panel avg: 140d · This submission: 231d
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 191
Devices cleared under the same product code (BTT) and FDA review panel - the closest regulatory comparables to K993355.
IPI HUMIDIFIER CHAMBER
K993282 · I.P.I. Medical Products · Sep 2000
HUMID-HEAT
K993773 · Hudson Rcj AB · Sep 2000
VAPOTHERM, MODEL 2000I
K000401 · Vapotherm, Inc. · Aug 2000
HME-BOOSTER
K990614 · King Systems Corp. · May 2000
MALLINCKRODT DAR HEATED WIRE BREATHING CIRCUIT
K993268 · Mallinckrodt Dar S.R.L. · Apr 2000
CLOUD 1 HUMIDIFICATION SYSTEM
K983862 · Respiratory Support Products, Inc. · May 1999
K993355 · HUDSON RCI CONCHA COLUMN, CAT. NO. 385-40 AND HUDSON RCI CIRCUIT, CAT. NO. 780-40, 780-41, 780-42, 780-43
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