510(k) · Cleared
ClearedEnterix Insurefit Fob Controls, Model 16800
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bionostics, Inc. · OSL Control, Fecal Occult Blood
Cleared on Oct 1, 2010 as substantially equivalent to K041297 (Polymedco, Inc., 2004) and 1 other predicate after a 92-day review. Its family tree reaches back 1 generation to 2004.
- Decided
- Oct 1, 2010
- Review
- 92 days
- Class
- Class II
- Product code
- OSL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K041297 (2004). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK041297 Polymedco OC Light Fobt TestPolymedco, Inc. · 2004 · Recalled
- This deviceK101831 Enterix Insurefit Fob Controls, Model 16800Bionostics, Inc. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K041297 | Polymedco OC Light Fobt Test | Polymedco, Inc. | 2004 | 1 |
| 0 (this device) | K101831 | Enterix Insurefit Fob Controls, Model 16800 | Bionostics, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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 OSL? 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 |
|---|---|---|---|
| * | K041297 | Polymedco OC Light Fobt TestSummary page 2…Product ~~Positive Control Positive Control Pstv oto 510(k), Date K101831, tbd K041297, 12 Aug 2004 K080812, 25 Jun 2008 Net Fill 1.5 mL 1.0 mL… | 2004 |
| * | K080812 | Hemoccult IctSummary page 1…Negative Control Negative Control 510(k), Date K101831, tbd KQ41297, 12 Aug 2004 K080812, 25 Jun 2008 Net Fill 1.5 mL 1.0 mL… | 2008 |
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?
- 2 of the 2 ancestors have a recall of any class.
- 1 other device also cites its predicate K041297.
How does its category compare?
All OSL devicesOSL Control, Fecal Occult Blood: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · OSL
1in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · OSL
Too few OSL 510(k)s in any year since 2007 to give a median.
Recalls per year · OSL
No recall names OSL since 2007.
Adverse event reports per year · OSL
1in 2024
MAUDE reports naming product code OSL, 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 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Enterix InSure FIT FOBT Controls are for in vitro diagnostic use only and include a positive control containing stabilized human hemoglobin and a negative control containing a buffer. This is an assayed positive and negative control and intended for the qualitative test determinations of Enterix Insure FIT product. Enterix InSure FIT FOBT Controls are for exclusive use with Enterix InSure FIT product. These controls can be used to independently verify the functionality and performance of the InSure FIT test by laboratories and other professional medical institutions as part of a comprehensive quality assurance program.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101831 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101831: Enterix Insurefit Fob Controls, Model 16800.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101831
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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