Cleared Traditional

K201077 - Strados Remote Electronic Stethoscope Platform (RESP)

K201077 is an FDA 510(k) clearance for Strados Remote Electronic Stethoscope P..., manufactured by Strados Labs. The device is a Class 2 Anesthesiology device with product code DSH cleared through the Traditional 510(k) pathway after a 242-day FDA review.

K201077 · Strados Labs · Anesthesiology device
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Dec 2020
Decision
242d
Days
Class 2
Risk

K201077 is an FDA 510(k) clearance for the Strados Remote Electronic Stethoscope Platform (RESP). Classified as Recorder, Magnetic Tape, Medical (product code DSH), Class II - Special Controls.

Submitted by Strados Labs (Philadelphia, US). The FDA issued a Cleared decision on December 20, 2020 after a review of 242 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 870.2800 - 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 Strados Labs devices

FDA 510(k) Submission Details - K201077

510(k) Number K201077 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 2020
Decision Date December 20, 2020
Days to Decision 242 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
102d slower than avg
Panel avg: 140d · This submission: 242d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSH Device Classification - Class 2, Special Controls

Product Code DSH Recorder, Magnetic Tape, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2800
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 Consultant

Powers Regulatory Consulting/64954
Grace Powers

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DSH Recorder, Magnetic Tape, Medical

All 112
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