Cleared Traditional

K250322 - Respond OC Conserving Regulator (130-0800)

K250322 is an FDA 510(k) clearance for Respond OC Conserving Regulator (130-0800), manufactured by Responsive Respiratory. The device is a Class 2 Anesthesiology device with product code NFB cleared through the Traditional 510(k) pathway after a 170-day FDA review.

K250322 · Responsive Respiratory · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2025
Decision
170d
Days
Class 2
Risk

K250322 is an FDA 510(k) clearance for the Respond OC Conserving Regulator (130-0800). Classified as Conserver, Oxygen (product code NFB), Class II - Special Controls.

Submitted by Responsive Respiratory (St. Louis, US). The FDA issued a Cleared decision on July 24, 2025 after a review of 170 days - an extended review cycle.

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 Responsive Respiratory devices

FDA 510(k) Submission Details - K250322

510(k) Number K250322 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 2025
Decision Date July 24, 2025
Days to Decision 170 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
30d slower than avg
Panel avg: 140d · This submission: 170d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NFB Device Classification - Class 2, Special Controls

Product Code NFB Conserver, Oxygen
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 Consultant

ProMedic, LLC
Paul Dryden

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 - NFB Conserver, Oxygen

All 17
Devices cleared under the same product code (NFB) and FDA review panel - the closest regulatory comparables to K250322.
Proxima
K220591 · Dynasthetics, LLC · Dec 2022
Effortless Oxygen Conserver System Models Effortless Pro and Effortless Mobile
K221014 · Effortless Oxygen, LLC · Oct 2022
Apogee
K200401 · Incoba Ltd D/B/A Dynaris · Nov 2020
Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula
K151506 · Salter Labs · Mar 2016
EOCD
K041568 · Respironics, Inc. · Jul 2004
EASY PULSE II OXYGEN CONSERVER
K032018 · Precision Medical, Inc. · Aug 2003