510(k) · Cleared
Recalled · Class III · 2018Collagen Reagent Cat. NO. 5368
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Helena Laboratories · GHR Reagent, Platelet Aggregation
Cleared on May 20, 1991 after an 89-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has been recalled 2 times.
- Decided
- May 20, 1991
- Review
- 89 days
- Class
- Class II
- Product code
- GHR
- Recalls
- 2
- Predicates
- 0
FDA has not posted a summary or statement for it, so its predicates are not known.
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 GHR? 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?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 23, 2018 | Class III | Z-0536-2020 | Unknown/Undetermined by firm | Through an investigation, it has been determined that vials of Collagen packaged within the Collagen Reagent and Platelet Aggregation Kit may contain particulate matter or microbial growth. |
| May 23, 2018 | Class III | Z-0537-2020 | Unknown/Undetermined by firm | Through an investigation, it has been determined that vials of Collagen packaged within the Collagen Reagent and Platelet aggregation Kit, may contain particulate matter or microbial growth. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All GHR devicesGHR Reagent, Platelet Aggregation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GHR
1in 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · GHR
Too few GHR 510(k)s in any year since 2007 to give a median.
Recalls per year · GHR
2in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GHR
No MAUDE report names GHR since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 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 | — | 2 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K910706 · printed Nov 3, 2026
Cite this page
510(k) Report. “K910706: Collagen Reagent Cat. NO. 5368.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K910706
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026