510(k) · Cleared
ClearedClinical Oxygen Dose Recorder (Codr), Model 300-CR
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inspired Technologies, Inc. · MNR Ventilatory Effort Recorder
Cleared on Mar 23, 2009 as substantially equivalent to K051313 (Salter Labs, 2005) and 1 other predicate after a 175-day review. Its family tree reaches back 5 generations to 1997.
- Decided
- Mar 23, 2009
- Review
- 175 days
- Class
- Class II
- Product code
- MNR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K962603 (1997). 15 ancestors in all, the oldest K913396 (1992). No later device cites it as a predicate yet.
- Root · 5 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 4 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 3 generations backK990966 Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric…Masimo Corp. · 1999
- 2 generations backK040595 ALICE 5Respironics, Inc. · 2004 · Recalled
- 1 generation backK061996 Sandman PocketEb Neuro S.P.A. · 2006
- This deviceK082853 Clinical Oxygen Dose Recorder (Codr), Model 300-CRInspired Technologies, Inc. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −4 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −3 | K990966 | Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric Disposable… | Masimo Corp. | 1999 | — |
| −2 | K040595 | ALICE 5 | Respironics, Inc. | 2004 | 1 |
| −1 | K061996 | Sandman Pocket | Eb Neuro S.P.A. | 2006 | — |
| 0 (this device) | K082853 | Clinical Oxygen Dose Recorder (Codr), Model 300-CR | Inspired Technologies, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MNR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MNR device
- #1 K244027 Sansa Hsatscore 18.1 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K051313 | BI-Naps Nasal Airflow and Snore TransducerSummary page 1…uency monitor Classification Name: breathing frequency monitor MNR - 868.2375 Predicate Devices: K051313 - Salter BiNAPS K061996 - EB Neuro - Sandman Device Description: The Inspired Technologies… | 2005 |
| * | K061996 | Sandman PocketSummary page 1…frequency monitor MNR - 868.2375 Predicate Devices: K051313 - Salter BiNAPS K061996 - EB Neuro - Sandman Device Description: The Inspired Technologies Clinical Oxygen Dose Recorder (CODR) Model 300 CR is a portab… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 4 companies; a new generation was cleared every 2.5 years on median.
- 1 of the 15 ancestors has a recall of any class.
- 2 other devices also cite its predicate K051313.
How does its category compare?
All MNR devicesMNR Ventilatory Effort Recorder: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · MNR
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MNR
165in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNR
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNR
43in 2025
MAUDE reports naming product code MNR, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 6 | 124 | 2 | 1 |
| 2008 | 14 | 118 | 0 | 0 |
| 2009 | 8 | 89 | 1 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 9 | 90 | 1 | 1 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 4 | 161 | 0 | 0 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 4 | 229 | 0 | 4 |
| 2016 | 3 | 281 | 0 | 10 |
| 2017 | 4 | 275 | 0 | 4 |
| 2018 | 3 | 147 | 0 | 2 |
| 2019 | 8 | 383 | 0 | 3 |
| 2020 | 5 | 192 | 0 | 5 |
| 2021 | 3 | 137 | 1 | 5 |
| 2022 | 7 | 266 | 0 | 4 |
| 2023 | 6 | 183 | 0 | 13 |
| 2024 | 6 | 217 | 0 | 11 |
| 2025 | 10 | 165 | 0 | 43 |
| 2026 | 5 | 227 | 1 | — |
What is it indicated for?
The Clinical Oxygen Dose Recorder (CODR) Model 300-CR records heart rate and oxygen saturation data provided by a Pulse oximeter; flow and pressure data from the oxygen delivery system; and measures breath rate and inhale/exhale ratio (I:E ratio) by monitoring the flow in the oxygen delivery tubing. Data is presented to enable the clinician to view the effects of the oxygen device's delivery performance on a patient in different ambulatory settings…
Read the full statement (124 words)
The Clinical Oxygen Dose Recorder (CODR) Model 300-CR records heart rate and oxygen saturation data provided by a Pulse oximeter; flow and pressure data from the oxygen delivery system; and measures breath rate and inhale/exhale ratio (I:E ratio) by monitoring the flow in the oxygen delivery tubing. Data is presented to enable the clinician to view the effects of the oxygen device's delivery performance on a patient in different ambulatory settings, i.e., rest and exercise. It is not to be used as a diagnostic tool.
The CODR is intended to be used by trained clinicians in the hospital, clinical or home care environments.
For the patient population the CODR will have the same indications for use as the oxygen-source to which it is attached.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082853 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082853: Clinical Oxygen Dose Recorder (Codr), Model 300-CR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082853
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026