Cleared Traditional

K822295 - SURGI TEK'S DISPOS. INNER CANNULA FOR

K822295 is an FDA 510(k) clearance for SURGI TEK'S DISPOS. INNER CANNULA FOR, manufactured by Medical Engineering Corp.. The device is a Class 2 Anesthesiology device with product code BTO cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K822295 · Medical Engineering Corp. · Anesthesiology device
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Aug 1982
Decision
18d
Days
Class 2
Risk

K822295 is an FDA 510(k) clearance for the SURGI TEK'S DISPOS. INNER CANNULA FOR. Classified as Tube, Tracheostomy (w/wo Connector) (product code BTO), Class II - Special Controls.

Submitted by Medical Engineering Corp. (Mchenry, US). The FDA issued a Cleared decision on August 20, 1982 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5800 - 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 Medical Engineering Corp. devices

FDA 510(k) Submission Details - K822295

510(k) Number K822295 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 1982
Decision Date August 20, 1982
Days to Decision 18 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
122d faster than avg
Panel avg: 140d · This submission: 18d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTO Device Classification - Class 2, Special Controls

Product Code BTO Tube, Tracheostomy (w/wo Connector)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5800
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 - BTO Tube, Tracheostomy (w/wo Connector)

All 58
Devices cleared under the same product code (BTO) and FDA review panel - the closest regulatory comparables to K822295.
H.R. JAKOBI SURG. INSTRUMENTS #9 48
K834179 · Imm Enterprises , Ltd. · Jan 1984
ARGYLE SILICONE TRACHESTOMY TUBE W/LOW
K831720 · Sherwood Medical Co. · Jul 1983
CONTAINERS OF STERILE WATER OS SALINE
K822811 · American Pharmaseal Div. Ahsc · Oct 1982
TRACH TAPE
K820099 · Stan-Pak Ent. · Feb 1982
SHILEY DISPOSABLE CANNULA TRACH. TUBE
K811447 · Shiley, Inc. · Jun 1981
SHILEY LOW PRESSURE THIN-CUFFED TRACH
K811033 · Shiley, Inc. · May 1981