510(k) · Cleared
ClearedMedical Gas Analyzer (AG200)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Prior Care Science Technology, Ltd. · CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Cleared on Aug 28, 2025 as substantially equivalent to K123043 (Phasein AB, 2012) after a 219-day review. Its family tree reaches back 5 generations to 1994.
- Decided
- Aug 28, 2025
- Review
- 219 days
- Class
- Class II
- Product code
- CCK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K935370 (1994). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK935370 Miniox IA Oxygen AnalyzerMinesafety Appliances Co. · 1994
- 4 generations backK973282 Handi Oxygen AnalyzerCeramatec, Inc. · 1998
- 3 generations backK051857 Veo Multigas Monitor for Pocket PC, Model 400221Weissburg Associates · 2005
- 2 generations backK081601 Veo Multigas Monitor for Pocket PCPhasein AB · 2008
- 1 generation backK123043 Irma C02 Model 200101; Irma AX 200601Phasein AB · 2012
- This deviceK250148 Medical Gas Analyzer (AG200)Prior Care Science Technology, Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K935370 | Miniox IA Oxygen Analyzer | Minesafety Appliances Co. | 1994 | — |
| −4 | K973282 | Handi Oxygen Analyzer | Ceramatec, Inc. | 1998 | — |
| −3 | K051857 | Veo Multigas Monitor for Pocket PC, Model 400221 | Weissburg Associates | 2005 | — |
| −2 | K081601 | Veo Multigas Monitor for Pocket PC | Phasein AB | 2008 | — |
| −1 | K123043 | Irma C02 Model 200101; Irma AX 200601 | Phasein AB | 2012 | — |
| 0 (this device) | K250148 | Medical Gas Analyzer (AG200) | Prior Care Science Technology, Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2011 | 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 CCK? 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 CCK device
- #1 K253030 Capnostream™35 Portable Respiratory Monitor…score 15.8 · 16 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 |
|---|---|---|---|
| * | K123043 | Irma C02 Model 200101; Irma AX 200601Summary page 6…1 Medical Gas Analyzer_Traditional 510k Submission 3. Predicate device information Predicate device 510(k) Number: K123043 Trade/ Device Name: IRMA-Infrared Mainstream Gas Analyzer Manufacturer: PHASEIN AB/ Masimo Sweden AB Regulation Name: Carbon diox… | 2012 |
| † | K042601 | Capnostat 5 | 2004 |
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 31 years and passes through 5 companies; a new generation was cleared every 4.1 years on median.
- 2 of the 10 ancestors have a recall of any class.
- 2 other devices also cite its predicate K123043.
How does its category compare?
All CCK devicesCCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · CCK
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CCK
169in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CCK
1in 2022
Class I (8 since 2007) Class II/III not classified
Adverse event reports per year · CCK
1,259in 2025
MAUDE reports naming product code CCK, 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 | 5 | 56 | 0 | 7 |
| 2008 | 3 | 248 | 1 | 20 |
| 2009 | 3 | 101 | 19 | 21 |
| 2010 | 3 | 125 | 4 | 12 |
| 2011 | 2 | — | 14 | 18 |
| 2012 | 7 | 150 | 3 | 13 |
| 2013 | 4 | 132 | 2 (1) | 28 |
| 2014 | 9 | 166 | 0 | 51 |
| 2015 | 5 | 105 | 1 | 114 |
| 2016 | 2 | — | 0 | 88 |
| 2017 | 5 | 134 | 0 | 58 |
| 2018 | 6 | 296 | 5 | 63 |
| 2019 | 7 | 261 | 7 (7) | 141 |
| 2020 | 4 | 188 | 1 | 2,302 |
| 2021 | 4 | 227 | 0 | 2,272 |
| 2022 | 3 | 226 | 1 | 2,475 |
| 2023 | 4 | 555 | 0 | 1,637 |
| 2024 | 3 | 592 | 0 | 1,216 |
| 2025 | 3 | 169 | 0 | 1,259 |
| 2026 | 3 | 224 | 0 | — |
What is it indicated for?
The Medical Gas Analyzer is intended to be connected to other medical devices for monitoring of the breathing gases C02, N20 and the anesthetic agents Halothane, Enflurane, Isoflurance, Sevoflurance and Desflurane.
It is intended to be connected to a patient breathing circuit for monitoring of inspired/expired gases during anesthesia, recovery and respiratory care. It may be used in the operating suite, intensive care unit and patient room for adult, pediatric and infant patients.The C02 may also be used in the emergency medical services environment and road ambulances.
Note: The Medical Gas Analyzer shall only be connected to medical devices approved by Prior-care.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250148 · printed Nov 4, 2026
Cite this page
510(k) Report. “K250148: Medical Gas Analyzer (AG200).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K250148
Report an extraction error
Are you the manufacturer?
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