510(k) · Cleared
ClearedElectra 1000C Automatic Coagulation Timer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Laboratory Automation Systems, Inc. · GKP Instrument, Coagulation, Automated
Cleared on Jul 27, 1989 after a 50-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 10 later devices descend from it.
- Decided
- Jul 27, 1989
- Review
- 50 days
- Class
- Class II
- Product code
- GKP
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 3 citing it directly.
- This deviceK894052 Electra 1000C Automatic Coagulation TimerMedical Laboratory Automation Systems, Inc. · 1989
- Descendant · cites it directly · 7 of its ownK964139 Sysmex CA-6000Dade Intl., Inc. · 1997
- Descendant · 2 generations on · 1 of its ownK020979 Sysmex Automated Coagulation Analyzer, Model #CA-7000Dade Behring, Inc. · 2002
- Descendant · 2 generations on · 1 of its ownK993299 Sysmex Automated Coagulation Analyzer, Model CA-1500Dade Behring, Inc. · 1999
- Descendant · 3 generations on · 0 of its ownK162420 Sysmex Automated Blood Coagulation Analyzer CS-5100Siemens Healthcare Diagnostics Products GmbH · 2016
- Descendant · 2 generations on · 0 of its ownK031377 Sysmex Automated Coagulation Analyzer CA500 Series (CA-510, -520…Dade Behring, Inc. · 2003
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K964139Sysmex CA-6000Dade Intl., Inc. · 1997 · cites it directly7descendants
- K020979Sysmex Automated Coagulation Analyzer, Model #CA-7000Dade Behring, Inc. · 2002 · 2 generations on1descendant
- K993299Sysmex Automated Coagulation Analyzer, Model CA-1500Dade Behring, Inc. · 1999 · 2 generations on1descendant
- K162420Sysmex Automated Blood Coagulation Analyzer CS-5100Siemens Healthcare Diagnostics Products GmbH · 2016 · 3 generations on0descendants
- K031377Sysmex Automated Coagulation Analyzer CA500 Series (CA-510, -520, -530, -540. -550, and…Dade Behring, Inc. · 2003 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K894052 | Electra 1000C Automatic Coagulation Timer | Medical Laboratory Automation Systems, Inc. | 1989 | — |
| +1 | K964139 | Sysmex CA-6000 | Dade Intl., Inc. | 1997 | — |
| +2 | K020979 | Sysmex Automated Coagulation Analyzer, Model #CA-7000 | Dade Behring, Inc. | 2002 | — |
| +2 | K993299 | Sysmex Automated Coagulation Analyzer, Model CA-1500 | Dade Behring, Inc. | 1999 | — |
| +3 | K162420 | Sysmex Automated Blood Coagulation Analyzer CS-5100 | Siemens Healthcare Diagnostics Products GmbH | 2016 | — |
| +2 | K031377 | Sysmex Automated Coagulation Analyzer CA500 Series (CA-510, -520, -530, -540.… | Dade Behring, Inc. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 4 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2016 | 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 GKP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GKP device
- #1 K242127 ACL TOP Family 50 Series (ACL TOP 750; ACL TOP…score 9.4 · 6 generations · no Class I recall
- #2 Held for the reportin 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? (10)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K964139 (Dade Intl., Inc., 1997) has gone furthest, with 7 descendants of its own.
How does its category compare?
All GKP devicesGKP Instrument, Coagulation, Automated: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GKP
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · GKP
Too few GKP 510(k)s in any year since 2007 to give a median.
Recalls per year · GKP
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GKP
5in 2024
MAUDE reports naming product code GKP, 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 | 1 | — | 3 | 3 |
| 2008 | 1 | — | 0 | 5 |
| 2009 | 1 | — | 0 | 190 |
| 2010 | 0 | — | 4 | 74 |
| 2011 | 0 | — | 0 | 45 |
| 2012 | 0 | — | 0 | 35 |
| 2013 | 0 | — | 0 | 42 |
| 2014 | 0 | — | 0 | 26 |
| 2015 | 1 | — | 0 | 24 |
| 2016 | 1 | — | 0 | 13 |
| 2017 | 0 | — | 0 | 18 |
| 2018 | 0 | — | 0 | 19 |
| 2019 | 0 | — | 0 | 38 |
| 2020 | 0 | — | 0 | 14 |
| 2021 | 0 | — | 0 | 17 |
| 2022 | 0 | — | 1 | 4 |
| 2023 | 1 | — | 0 | 4 |
| 2024 | 1 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K894052 · printed Nov 6, 2026
Cite this page
510(k) Report. “K894052: Electra 1000C Automatic Coagulation Timer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K894052
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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