510(k) · Cleared
ClearedHandi Oxygen Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ceramatec, Inc. · CCL Analyzer, Gas, Oxygen, Gaseous-Phase
Cleared on Mar 4, 1998 as substantially equivalent to K935370 (Minesafety Appliances Co., 1994) after a 183-day review. Its family tree reaches back 1 generation to 1994. 3 of the 30 devices in its family, counting itself, have a Class I recall. 28 later devices descend from it.
- Decided
- Mar 4, 1998
- Review
- 183 days
- Class
- Class II
- Product code
- CCL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K935370 (1994). 28 later devices descend from it, 3 citing it directly. 3 of the 30 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK935370 Miniox IA Oxygen AnalyzerMinesafety Appliances Co. · 1994
- This deviceK973282 Handi Oxygen AnalyzerCeramatec, Inc. · 1998
- Descendant · cites it directly · 16 of its ownK051857 Veo Multigas Monitor for Pocket PC, Model 400221Weissburg Associates · 2005
- Descendant · 2 generations on · 12 of its ownK081601 Veo Multigas Monitor for Pocket PCPhasein AB · 2008
- Descendant · 3 generations on · 11 of its ownK123043 Irma C02 Model 200101; Irma AX 200601Phasein AB · 2012
- Descendant · cites it directly · 10 of its ownK023565 OxicheckCaradyne, Ltd. · 2003
- Descendant · 2 generations on · 9 of its ownK040484 MAXO2+, Model a and AEMaxtec, Inc. · 2004
Showing 5 of 28 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 28 · See all- K051857Veo Multigas Monitor for Pocket PC, Model 400221Weissburg Associates · 2005 · cites it directly16descendants
- K081601Veo Multigas Monitor for Pocket PCPhasein AB · 2008 · 2 generations on12descendants
- K123043Irma C02 Model 200101; Irma AX 200601Phasein AB · 2012 · 3 generations on11descendants
- K023565OxicheckCaradyne, Ltd. · 2003 · cites it directly10descendants
- K040484MAXO2+, Model a and AEMaxtec, Inc. · 2004 · 2 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K935370 | Miniox IA Oxygen Analyzer | Minesafety Appliances Co. | 1994 | — |
| 0 (this device) | K973282 | Handi Oxygen Analyzer | Ceramatec, Inc. | 1998 | — |
| +1 | K051857 | Veo Multigas Monitor for Pocket PC, Model 400221 | Weissburg Associates | 2005 | — |
| +2 | K081601 | Veo Multigas Monitor for Pocket PC | Phasein AB | 2008 | — |
| +3 | K123043 | Irma C02 Model 200101; Irma AX 200601 | Phasein AB | 2012 | — |
| +1 | K023565 | Oxicheck | Caradyne, Ltd. | 2003 | — |
| +2 | K040484 | MAXO2+, Model a and AE | Maxtec, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 2 |
| 2020 | 1 | 0 |
| 2021 | 2 | 1 |
| 2024 | 2 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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.
3 devices in this family have a Class I recall. 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? (1)
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 |
|---|---|---|---|
| * | K935370 | Miniox IA Oxygen AnalyzerSummary page 1…ary Device Name: Ceramatec® Handi 6.0 Classification Name: Oxygen Gas Analyzer 7.0 Common Name: Oxygen Analyzer 8.0 Predicate Device: MSA Miniox® Ia oxygen analyzer (K935370) 9.0 Device Function: \ \ [ UEEEND ¥ G A MAR -4 1998 The device function of the Ceramatec® Handi oxygen analyzer is to monito… | 1994 |
What descends from it? (28)
See all 283 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (3 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K181170Trilogy Evo UniversalRespironics, Inc. · 2019 · 5 generations on · ◆ in the 2019 descendants bar of FIG. 112 Class I recalls
- K193586Vivo 45 LSBreas Medical AB · 2021 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
- K181166Trilogy EvoRespironics, Inc. · 2019 · 5 generations on · ◆ in the 2019 descendants bar of FIG. 131 Class I recalls
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K051857 (Weissburg Associates, 2005) has gone furthest, with 16 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 | — |
What is it indicated for?
Purpose: The purpose of the Ceramatec® Handi oxygen analyzer is to monitor oxygen concentration in the patient breathing environment. Function: The Ceramatec® Handi oxygen analyzer measures the oxygen partial pressure of a gas stream, and displays a digital reading of the oxygen concentration of the measured gas on a liquid-crystal display (LCD). Target Patient Population: The target patient population consists of patients who require the oxygen…
Read the full statement (124 words)
Purpose: The purpose of the Ceramatec® Handi oxygen analyzer is to monitor oxygen concentration in the patient breathing environment.
Function: The Ceramatec® Handi oxygen analyzer measures the oxygen partial pressure of a gas stream, and displays a digital reading of the oxygen concentration of the measured gas on a liquid-crystal display (LCD).
Target Patient Population: The target patient population consists of patients who require the oxygen concentration in their environment to be monitored.
Environment of Use: The Ceramatec® Handi oxygen analyzer is used in patient breathing environments whose temperatures range from 10 to 40 °C, and whose relative humidity ranged from 0 - 95% (non-condensing).
Device Claims: The Ceramatec® Handi oxygen analyzer has the claim of monitoring percent-oxygen concentration in the patient breathing environment.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K973282 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973282: Handi Oxygen Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973282
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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