510(k) · Cleared
ClearedPRO2 Check Oxygen Indicator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Technology Specialists, Inc. · CCL Analyzer, Gas, Oxygen, Gaseous-Phase
Cleared on Mar 17, 1999 after a 162-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it.
- Decided
- Mar 17, 1999
- Review
- 162 days
- Class
- Class II
- Product code
- CCL
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK983500 PRO2 Check Oxygen IndicatorMedical Technology Specialists, Inc. · 1999
- Descendant · cites it directly · 3 of its ownK072469 Digiflo Concentrator AnalyzerDigiflo, Inc. · 2008
- Descendant · cites it directly · 2 of its ownK112402 ULTRAMAXO2 Oxygen AnalyerMaxtec, LLC · 2011
- Descendant · 2 generations on · 0 of its ownK261389 PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)Salter Labs · 2026
- Descendant · 2 generations on · 0 of its ownK250002 Smart Check O2 (MA0236)Life Spark Medical, LLC · 2025
Most influential descendants
Showing 4 of 4 · See all- K072469Digiflo Concentrator AnalyzerDigiflo, Inc. · 2008 · cites it directly3descendants
- K112402ULTRAMAXO2 Oxygen AnalyerMaxtec, LLC · 2011 · cites it directly2descendants
- K261389PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)Salter Labs · 2026 · 2 generations on0descendants
- K250002Smart Check O2 (MA0236)Life Spark Medical, LLC · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K983500 | PRO2 Check Oxygen Indicator | Medical Technology Specialists, Inc. | 1999 | — |
| +1 | K072469 | Digiflo Concentrator Analyzer | Digiflo, Inc. | 2008 | — |
| +1 | K112402 | ULTRAMAXO2 Oxygen Analyer | Maxtec, LLC | 2011 | — |
| +2 | K261389 | PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1) | Salter Labs | 2026 | — |
| +2 | K250002 | Smart Check O2 (MA0236) | Life Spark Medical, LLC | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CCL? 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 CCL device
- #1 K261389 PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)score 12.7 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K072469 (Digiflo, Inc., 2008) has gone furthest, with 3 descendants of its own.
How does its category compare?
All CCL devicesCCL Analyzer, Gas, Oxygen, Gaseous-Phase: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CCL
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CCL
Too few CCL 510(k)s in any year since 2007 to give a median.
Recalls per year · CCL
1in 2009
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CCL
2in 2025
MAUDE reports naming product code CCL, 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 | 2 | — | 0 | 1 |
| 2008 | 2 | — | 0 | 2 |
| 2009 | 0 | — | 1 | 2 |
| 2010 | 0 | — | 0 | 5 |
| 2011 | 1 | — | 0 | 4 |
| 2012 | 0 | — | 0 | 5 |
| 2013 | 2 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 8 |
| 2015 | 0 | — | 0 | 5 |
| 2016 | 1 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 4 |
| 2025 | 2 | — | 0 | 2 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/K983500 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983500: PRO2 Check Oxygen Indicator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983500
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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