Cleared Traditional

K260671 - RP Check (RP01)

K260671 is an FDA 510(k) clearance for RP Check (RP01), manufactured by MD Diagnostics, Ltd.. The device is a Class 2 Anesthesiology device with product code CAP cleared through the Traditional 510(k) pathway after a 238-day FDA review.

K260671 · MD Diagnostics, Ltd. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
238d
Days
Class 2
Risk

K260671 is an FDA 510(k) clearance for the RP Check (RP01). Classified as Monitor, Airway Pressure (includes Gauge And/or Alarm) (product code CAP), Class II - Special Controls.

Submitted by MD Diagnostics, Ltd. (Chatham, GB). The FDA issued a Cleared decision on October 26, 2026 after a review of 238 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2600 - 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.

FDA 510(k) Submission Details - K260671

510(k) Number K260671 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2026
Decision Date October 26, 2026
Days to Decision 238 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d slower than avg
Panel avg: 140d · This submission: 238d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAP Device Classification - Class 2, Special Controls

Product Code CAP Monitor, Airway Pressure (includes Gauge And/or Alarm)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2600
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 - CAP Monitor, Airway Pressure (includes Gauge And/or Alarm)

All 75
Devices cleared under the same product code (CAP) and FDA review panel - the closest regulatory comparables to K260671.
SINGLE USE MANOMETER
K201666 · Flexicare Medical Limited. · Nov 2020
VORTRAN APM-Plus
K182292 · Vortran Medical Technology 1, Inc. · Sep 2019
NS 120P-TRS Airway Pressure Gauge
K180510 · Instrumentation Industries, Inc. · May 2019
NAPA LP-15 Airway Pressure Monitor
K172284 · Drw Medical, LLC · Feb 2018
VORTRAN Manometer
K153733 · Vortran Medical Technology 1, Inc. · Sep 2016
Disposable Pressure Manometer (DPM)
K143148 · Westmed, Inc. · Aug 2015
K260671 · RP Check (RP01)
Download PDF FDA Summary MD Diagnostics, Ltd.