Cleared Traditional

K000215 - SWIVEL ELBOW

K000215 is an FDA 510(k) clearance for SWIVEL ELBOW, manufactured by Engineered Medical Systems. The device is a Class 2 Anesthesiology device with product code BZD cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K000215 · Engineered Medical Systems · Anesthesiology device
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May 2000
Decision
123d
Days
Class 2
Risk

K000215 is an FDA 510(k) clearance for the SWIVEL ELBOW. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Engineered Medical Systems (Indianapolis, US). The FDA issued a Cleared decision on May 26, 2000 after a review of 123 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5905 - 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 Engineered Medical Systems devices

FDA 510(k) Submission Details - K000215

510(k) Number K000215 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 2000
Decision Date May 26, 2000
Days to Decision 123 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
17d faster than avg
Panel avg: 140d · This submission: 123d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZD Device Classification - Class 2, Special Controls

Product Code BZD Ventilator, Non-continuous (respirator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5905
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 - BZD Ventilator, Non-continuous (respirator)

All 446
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K000215.
BREAS PV 100 CPAP SYSTEM
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MALLINCKRODT, GOODKNIGHT 418S
K001845 · Mallinckrodt Developpement France · Jul 2000
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K000994 · Respironics, Inc. · Jun 2000
AIRPILOTMASK, MODEL TMS-900
K992192 · Tiara Medical Systems, Inc. · May 2000
MALLINCKRODT, GOODKNIGHT 418A, GOODKNIGHT 418P, SILVERLINING 2
K993584 · Nellcor Puritan Bennett France Dvpt. · Mar 2000
HERITAGE NASAL CPAP SYSTEM, MODEL P/N 15682
K990856 · Bird Products Corp. · Jan 2000