510(k) · Cleared
ClearedPoc-AS10 Auto Sampler
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Otsuka Pharmaceutical Co., Ltd. · MSQ Test, Urea (Breath Or Blood)
Cleared on Mar 9, 2010 after a 176-day review. The FDA summary names its predicate without a number.
- Decided
- Mar 9, 2010
- Review
- 176 days
- Class
- Class I
- Product code
- MSQ
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 MSQ? 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 MSQ device
- #1 K220494 BreathID Hp Lab System, BreathID Smart Systemscore 8.4 · 7 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 |
|---|---|---|---|
| * | — | POCone Infrared Spectrophotometer Named without a submission number | |
| * | — | UBiT-1R300 Infrared Spectrometry System Named without a submission number |
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.
How does its category compare?
All MSQ devicesMSQ Test, Urea (Breath Or Blood): FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · MSQ
3in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · MSQ
121in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MSQ
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MSQ
1in 2025
MAUDE reports naming product code MSQ, 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 | 0 | — | 1 | 2 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 0 | — | 1 | 2 |
| 2012 | 0 | — | 0 | 4 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 4 |
| 2016 | 1 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 3 | 121 | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The POCone Infrared Spectrophotometer is an in vitro diagnostic device designed to measure changes in 13C0 2 content in breath CO 2 gas by infrared spectroscopic analysis.. The POC-AS 10 Auto sampler expands the number of breath collection bags that can be set up and analyzed by the POCone Infrared Spectrophotometer.
The POCone hifirared Spectrophotometer is intended for use in conjunction with commercially available Meretek 13 C-urea breath tests for the detection of Helicobacterpylori (H.pylori) infection. The POCone Infrared Spectrophotometer is suitable for use in both point of care and clinical laboratory settings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092817 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092817: Poc-AS10 Auto Sampler.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092817
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)
- Page last updated Nov 3, 2026