510(k) · Cleared
ClearedMulti-Function Blood Gas Control
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bionostics, Inc. · JJY Multi-Analyte Controls, All Kinds (Assayed)
Cleared on May 27, 1988 after a 115-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- May 27, 1988
- Review
- 115 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 4 citing it directly.
- This deviceK880447 Multi-Function Blood Gas ControlBionostics, Inc. · 1988
- Descendant · cites it directly · 1 of its ownK974822 Avl Opti-Check PH/ Blood Gas/ Electrolyte/THB/ SO2 ControlAvl Scientific Corp. · 1998
- Descendant · cites it directly · 0 of its ownK093384 Mission Trinity R (Level 1) (Level 2) (Level 3), (Level 1,2,3)Diamond Diagnostics, Inc. · 2010 · Recalled
- Descendant · cites it directly · 0 of its ownK053327 Oxicom ControlBionostics, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK021930 Medica Easyqc Blood Gas/Electrolyte ControlBionostics, Inc. · 2002
Most influential descendants
Showing 4 of 4 · See all- K974822Avl Opti-Check PH/ Blood Gas/ Electrolyte/THB/ SO2 ControlAvl Scientific Corp. · 1998 · cites it directly1descendant
- K093384Mission Trinity R (Level 1) (Level 2) (Level 3), (Level 1,2,3)Diamond Diagnostics, Inc. · 2010 · cites it directly0descendants
- K053327Oxicom ControlBionostics, Inc. · 2006 · cites it directly0descendants
- K021930Medica Easyqc Blood Gas/Electrolyte ControlBionostics, Inc. · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K880447 | Multi-Function Blood Gas Control | Bionostics, Inc. | 1988 | — |
| +1 | K974822 | Avl Opti-Check PH/ Blood Gas/ Electrolyte/THB/ SO2 Control | Avl Scientific Corp. | 1998 | — |
| +1 | K093384 | Mission Trinity R (Level 1) (Level 2) (Level 3), (Level 1,2,3) | Diamond Diagnostics, Inc. | 2010 | 1 |
| +1 | K053327 | Oxicom Control | Bionostics, Inc. | 2006 | — |
| +1 | K021930 | Medica Easyqc Blood Gas/Electrolyte Control | Bionostics, Inc. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JJY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
4 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, K974822 (Avl Scientific Corp., 1998) has gone furthest, with 1 descendant of its own.
How does its category compare?
All JJY devicesJJY Multi-Analyte Controls, All Kinds (Assayed): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JJY
3in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JJY
78in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JJY
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJY
13in 2025
MAUDE reports naming product code JJY, 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 | 11 | 49 | 5 | 2 |
| 2008 | 7 | 54 | 0 | 1 |
| 2009 | 8 | 80 | 2 | 3 |
| 2010 | 10 | 109 | 6 | 3 |
| 2011 | 14 | 120 | 1 | 6 |
| 2012 | 13 | 40 | 3 | 20 |
| 2013 | 16 | 82 | 2 | 5 |
| 2014 | 10 | 49 | 2 | 4 |
| 2015 | 4 | 153 | 1 | 4 |
| 2016 | 1 | — | 3 | 13 |
| 2017 | 3 | 78 | 4 | 12 |
| 2018 | 0 | — | 3 | 7 |
| 2019 | 0 | — | 4 | 1 |
| 2020 | 0 | — | 6 | 7 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 3 | 0 |
| 2023 | 0 | — | 3 | 4 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 2 | 13 |
| 2026 | 0 | — | 1 | — |
https://510kreport.com/device/K880447 · printed Nov 6, 2026
Cite this page
510(k) Report. “K880447: Multi-Function Blood Gas Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K880447
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026