Cleared Special

Maximus System (K200988) - FDA 510(k) Clearance

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

K200988 · Hill-Rom Services Pte, Ltd. · Anesthesiology device
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May 2020
Decision
41d
Days
Class 2
Risk

K200988 is an FDA 510(k) clearance for the Maximus System. Classified as Device, Positive Pressure Breathing, Intermittent (product code NHJ), Class II - Special Controls.

Submitted by Hill-Rom Services Pte, Ltd. (Singapore, SG). The FDA issued a Cleared decision on May 26, 2020 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5905 - 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Hill-Rom Services Pte, Ltd. devices

Submission Details

510(k) Number K200988 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 2020
Decision Date May 26, 2020
Days to Decision 41 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
98d faster than avg
Panel avg: 139d · This submission: 41d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code NHJ Device, Positive Pressure Breathing, Intermittent
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.