510(k) · Cleared
Recalled · 2004Icrotaineo Brand Tube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bd Becton Dickinson Vacutainer Systems Preanalytic · GJE Tray, Blood Collection
Cleared on Aug 3, 1977 after a 9-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it. It has been recalled once.
- Decided
- Aug 3, 1977
- Review
- 9 days
- Class
- Class II
- Product code
- GJE
- Recalls
- 1
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK771370 Icrotaineo Brand TubeBd Becton Dickinson Vacutainer Systems Preanalytic · 1977
- Descendant · cites it directly · 2 of its ownK991702 Microtainer Brand Chemistry Tubes with Microgard Closure, Model…Becton Dickinson Vacutainer Systems · 1999 · Recalled
- Descendant · 2 generations on · 1 of its ownK230391 BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™…Becton, Dickinson and Company · 2023
- Descendant · 3 generations on · 0 of its ownK252378 BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™…Becton, Dickinson and Company · 2026
Most influential descendants
Showing 3 of 3 · See all- K991702Microtainer Brand Chemistry Tubes with Microgard Closure, Model 365965, 365985, 365963…Becton Dickinson Vacutainer Systems · 1999 · cites it directly2descendants
- K230391BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ SST™ Capillary Blood…Becton, Dickinson and Company · 2023 · 2 generations on1descendant
- K252378BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™ Capillary Blood…Becton, Dickinson and Company · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K771370 | Icrotaineo Brand Tube | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1977 | — |
| +1 | K991702 | Microtainer Brand Chemistry Tubes with Microgard Closure, Model 365965… | Becton Dickinson Vacutainer Systems | 1999 | 9 |
| +2 | K230391 | BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ SST™… | Becton, Dickinson and Company | 2023 | — |
| +3 | K252378 | BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™… | Becton, Dickinson and Company | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 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 GJE? 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? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K991702 | Microtainer Brand Chemistry Tubes with Microgard Closure, Model 365965, 365985, 365963… | 1999 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 20, 2004 | Not classified | Z-1603-05 | Other | "Please be aware that this is not a new recall. This recall was initially classified in 2005 (Z-0052-05). The firm has taken action; but, due to administrative issues additional products are now being classified by the agency". There is… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K991702 (Becton Dickinson Vacutainer Systems, 1999) has gone furthest, with 2 descendants of its own.
How does its category compare?
All GJE devicesGJE Tray, Blood Collection: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GJE
FDA has decided no GJE device since 2007.
Median 510(k) review, days · GJE
Too few GJE 510(k)s in any year since 2007 to give a median.
Recalls per year · GJE
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GJE
3in 2014
MAUDE reports naming product code GJE, 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 | 7 |
| 2008 | 0 | — | 0 | 3 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 3 |
| 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 | — | 1 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K771370 · printed Nov 6, 2026
Cite this page
510(k) Report. “K771370: Icrotaineo Brand Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K771370
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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