510(k) · Cleared
ClearedOxicom Control
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bionostics, Inc. · JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Cleared on Jan 26, 2006 as substantially equivalent to K921519 (Waters Instruments, Inc., 1992) and 2 other predicates after a 56-day review. Its family tree reaches back 2 generations to 1988.
- Decided
- Jan 26, 2006
- Review
- 56 days
- Class
- Class I
- Product code
- JJX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K880447 (1988). 4 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | 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 | — |
| 0 (this device) | K053327 | Oxicom Control | Bionostics, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 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 JJX? 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? (3)
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 |
|---|---|---|---|
| * | K921519 | Oxicom-2100Summary page 1…Control for Waters Control Control Oxicom 510(k): -- K921519 K974822 K880447 Description: Aqueous solution 1translucent plastic A… | 1992 |
| * | K974822 | Avl Opti-Check PH/ Blood Gas/ Electrolyte/THB/ SO2 ControlSummary page 1…Control Control Oxicom 510(k): -- K921519 K974822 K880447 Description: Aqueous solution 1translucent plastic Aqueous solution… | 1998 |
| * | K880447 | Multi-Function Blood Gas ControlSummary page 1…trol Control Oxicom 510(k): -- K921519 K974822 K880447 Description: Aqueous solution 1translucent plastic Aqueous solution Aqueous solution… | 1988 |
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 18 years and passes through 2 companies; a new generation was cleared every 9.7 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All JJX devicesJJX Single (Specified) Analyte Controls (Assayed And Unassayed): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JJX
2in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JJX
31in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JJX
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJX
22in 2025
MAUDE reports naming product code JJX, 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 | 6 | 53 | 3 | 2 |
| 2008 | 8 | 52 | 3 | 0 |
| 2009 | 17 | 80 | 0 | 1 |
| 2010 | 24 | 80 | 3 | 6 |
| 2011 | 19 | 62 | 2 | 62 |
| 2012 | 15 | 40 | 0 | 32 |
| 2013 | 19 | 37 | 0 | 51 |
| 2014 | 22 | 30 | 1 | 48 |
| 2015 | 11 | 65 | 1 | 67 |
| 2016 | 6 | 31 | 2 | 37 |
| 2017 | 2 | — | 0 | 19 |
| 2018 | 0 | — | 2 | 35 |
| 2019 | 0 | — | 0 | 82 |
| 2020 | 0 | — | 0 | 77 |
| 2021 | 0 | — | 1 | 43 |
| 2022 | 0 | — | 0 | 24 |
| 2023 | 0 | — | 0 | 22 |
| 2024 | 0 | — | 0 | 30 |
| 2025 | 0 | — | 0 | 22 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Oxicom Control is intended to be used to monitor and evaluate the analytical performance of the Waters Oxicom models 2000, 2100 and 3000 oxygen saturation meters for the measurement of oxygen saturation. The use of quality control materials is indicated as an objective assessment of the precision of methods and techniques in use and is an integral part of good laboratory practice. The three levels of oxygen saturation provided by the controls allow performance monitoring within the clinically important range.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053327 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053327: Oxicom Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053327
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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