Cleared Special

K220976 - Life Scope PT BSM-1700 Series Bedside Monitor (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K220976 · Nihon Kohden Corporation · Anesthesiology device
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Optimized for regulatory review, auditing and printing
Jul 2022
Decision
108d
Days
Class 2
Risk

K220976 is an FDA 510(k) clearance for the Life Scope PT BSM-1700 Series Bedside Monitor. Classified as Stimulator, Nerve, Peripheral, Electric (product code KOI), Class II - Special Controls.

Submitted by Nihon Kohden Corporation (Tokyo, JP). The FDA issued a Cleared decision on July 21, 2022 after a review of 108 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2775 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Nihon Kohden Corporation devices

Submission Details

510(k) Number K220976 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2022
Decision Date July 21, 2022
Days to Decision 108 days
Submission Type Special
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
31d faster than avg
Panel avg: 139d · This submission: 108d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code KOI Stimulator, Nerve, Peripheral, Electric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2775
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

Nihon Koden America, Inc.
Sunita Teekasingh

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 - KOI Stimulator, Nerve, Peripheral, Electric

All 27
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