510(k) · Cleared
ClearedOxyhemoglobin Control for CO-Oximetry
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 Feb 12, 1998 as substantially equivalent to K832066 (Bio-Nustics, Inc., 1983) and 1 other predicate after a 23-day review. Its family tree reaches back 1 generation to 1983.
- Decided
- Feb 12, 1998
- Review
- 23 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K832066 (1983). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK832066 Control 282Bio-Nustics, Inc. · 1983
- This deviceK980178 Oxyhemoglobin Control for CO-OximetryBionostics, Inc. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K832066 | Control 282 | Bio-Nustics, Inc. | 1983 | — |
| 0 (this device) | K980178 | Oxyhemoglobin Control for CO-Oximetry | Bionostics, Inc. | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 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 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? (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 |
|---|---|---|---|
| * | K832066 | Control 282Summary page 1…Control is substantially equivalent in function, safety and efficacy to at least two products currently marketed: a. Bionostics 282 CO-Oximeter Control (510(k) clearance K832066A, 6/22/83), and, b.Multi-4 CO-Oximeter Control manufactured by Instrumentation Laboratory, Lexington, MA 02173 (510(k) clearance… | 1983 |
| * | K861901 | Multi-4 CO-Oximeter ControlSummary page 1…imeter Control (510(k) clearance K832066A, 6/22/83), and, b.Multi-4 CO-Oximeter Control manufactured by Instrumentation Laboratory, Lexington, MA 02173 (510(k) clearance K861901). Both materials have as their intended use, the quality control of certain analytical instruments. (4) Description of the new de… | 1986 |
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?
- None of the 2 ancestors has a recall.
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 | — |
What is it indicated for?
The measurement of the concentrations of total hemoglobin,
oxyhemoglobin, carboxyhemoglobin, and methemoglobin can serve to
monitor tissue oxygenation and therefore the various metabolic factors
which effect oxygen transport of blood. Since therapeutic regimes are
often determined by the result obtained in patient samples, the
instruments used for these analyses must meet clinical requirements
for precision and accuracy. The use of control materials are designed
to verify test results and assist in identifying instrument
calibration or operating problems.
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/K980178 · printed Nov 4, 2026
Cite this page
510(k) Report. “K980178: Oxyhemoglobin Control for CO-Oximetry.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980178
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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