510(k) · Cleared
ClearedPocone Infrared Spectrophotometer
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 Jul 15, 2004 as substantially equivalent to K013371 (Otsuka Pharmaceutical Co., Ltd., 2001) after a 73-day review. Its family tree reaches back 2 generations to 1997.
- Decided
- Jul 15, 2004
- Review
- 73 days
- Class
- Class I
- Product code
- MSQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K974322 (1997). No later device cites it as a predicate yet.
- Root · 2 generations backK974322 Abca-NT Gas Isotope Ratio Mass Spectrometer SystemEuropa Scientific, Ltd. · 1997
- 1 generation backK013371 Ubit-IR300 Infrared Spectrometry SystemOtsuka Pharmaceutical Co., Ltd. · 2001 · Recalled
- This deviceK041148 Pocone Infrared SpectrophotometerOtsuka Pharmaceutical Co., Ltd. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K974322 | Abca-NT Gas Isotope Ratio Mass Spectrometer System | Europa Scientific, Ltd. | 1997 | — |
| −1 | K013371 | Ubit-IR300 Infrared Spectrometry System | Otsuka Pharmaceutical Co., Ltd. | 2001 | 1 |
| 0 (this device) | K041148 | Pocone Infrared Spectrophotometer | Otsuka Pharmaceutical Co., Ltd. | 2004 | — |
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? (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 |
|---|---|---|---|
| * | K013371 | Ubit-IR300 Infrared Spectrometry SystemSummary page 1…Urea Breath Test 3. PREDICATE DEVICE * UBiT-IR300 Infrared Spectrophotometer Otsuka Pharmaceutical Co., Ltd. K013371 Otsuka Pharmaceutical Co., Ltd. 5 10(k) April 30, 2004 POCone Infrared Spectrophotometer… | 2001 |
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 7 years and passes through 2 companies; a new generation was cleared every 4.0 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 2 other devices also cite its predicate K013371.
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.
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 13CO2 content in breath CO2 gas by infrared spectroscopic analysis.
The POCone Infrared Spectrophotometer is intended for use in conjunction with
commercially available Meretek "3C-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/K041148 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041148: Pocone Infrared Spectrophotometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041148
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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