Tool · 510(k)

510(k) Predicate Finder

Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.

Product Code: NFB FDA class 2

Conserver, Oxygen

Anesthesiology

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The Conserver, Oxygen (product code NFB) is an anesthesiology device designed to reduce oxygen consumption by delivering oxygen only during inhalation, extending the life of portable oxygen cylinders for patients requiring supplemental oxygen therapy. It is classified as an FDA Class 2 device within the Anesthesiology specialty, requiring 510(k) premarket clearance. No specific regulation number has been assigned to this product code. The device is not flagged as an implant or life-sustaining device.

510(k) Clearances

50+ matches
K Number
Device Name
Proxima
Effortless Oxygen Conserver System Models Effortless Pro and Effortless Mobile
Apogee
Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula
THERAFLOW SINGLE LUMEN AND THERAFLOW DUAL LUMEN
CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER WITH MOTION
CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER
MODEL 350G GAS CONSERVER
CHAD THERAPEUTICS BONSAI MODEL 800
INOVO, INC. ACCUPULSE SINGLE LUMEN CONSERVING REGULATOR
FLO-RITE, MODEL 478-1; FLO-RITE II, MODEL 478-1; SIMPULSE II, MODEL 478-2S; NUMATIX, MODEL NCD401; SIMPULSE, MODEL 478-1
INOGEN SATELLITE CONSERVER, MODEL SC-100
OXY-SERVE II OXYGEN CONSERVING REGULATOR
INOVO, INC. INDEPENDENCE OXYGEN CONSERVING REGULATOR
ACCU02 SYSTEM
CHAD THERAPEUTICS LOTUS, MODELS OM-700 AND OM-700S
FLO-RITE
EOCD
INOGEN SATELLITE CONSERVER
CHAD THERAPEUTICS SAGE
ESSEX HIGH PRESSURE (HP) OCD AND ESSEX ESCORT PNEUMATIC CONSERVER
INOVO, INC, ECONOMIZER CONSERVING REGULATOR
EASY PULSE II OXYGEN CONSERVER
AIRLIFE DEMAND NASAL CANNULA
6203
PULSED OXYGEN CONSERVING DEVICE - EVERY BREATH, POCDEB, REACTEB
CHAD THERAPEUTICS OXYPENUMATIC CYPRESS MODEL 511
DEVILBISS PD1000
OPC OXYGEN CONSERVING REGULATOR, MODEL AHG 1968, LIN-7005, MDL-7609, MEM-7612, OPC-830
CHAD THERAPEUTICS OXYMATIC MODEL 401 AND OXYMATIC MODEL 411
PM 1800 CONSERVING DEVICE
MODIFICATION TO CHAD THERAPEUTICS OXYMATIC MODEL 401
VENTURE IDD OXYGEN CONSERVING DEVICE IDD 20EX AND 50EX
IMPULSE SELECT
OCD2001
CHAD THERAPEUTICS OXYMATIC MODEL 401
O2N DEMAND-II, VICTOR MODEL OCPR-II
TRANSTRACHEAL DEMAND OXYGEN CONTROLLER MODEL DOC-3000
PNEUMATIC DEMAND OXYGEN CONSERVER (PDOC)
DEMAND OXYGEN CONSERVING DEVICE, DOCD, THE DOC
PULSED OXYGEN CONSERVING DEVICE, POCD
SANPO I
FLOTEC OXYSAVRR (S)
VICTOR MODEL OCPR OXYGEN CONSERVING PRESSURE REGULATOR
TRANSTRACHEAL DEMAND OXYGEN CONTROLLER (DOC-2000)
PULSE DOSE SERIES
AIRSEP IMPULSE
OXYPULSE EOC I, EOC II & EOC R
MODEL IPD OXYGEN CONSERVING DEVICE
MEDISONIC OXYGEN FLOW CONTROLLER

What is a Predicate Device?

A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.

Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.

Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.

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