510(k) · Cleared
ClearedGikter Ecg Cassette Tape Recorder Model XR 300
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Datrix · DSH Recorder, Magnetic Tape, Medical
Cleared on Mar 30, 1992 after a 24-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 7 later devices descend from it.
- Decided
- Mar 30, 1992
- Review
- 24 days
- Class
- Class II
- Product code
- DSH
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 2 citing it directly.
- This deviceK921068 Gikter Ecg Cassette Tape Recorder Model XR 300Datrix · 1992
- Descendant · cites it directly · 5 of its ownK982975 Digital Ecg Holter Recorder, Model DR512Datrix · 1998
- Descendant · 2 generations on · 2 of its ownK062007 DMS 300-7Diagnostic Monitoring Software · 2006
- Descendant · 3 generations on · 1 of its ownK062959 DMS 300-2, 300-3 and 300-4Diagnostic Monitoring Software · 2006
- Descendant · 2 generations on · 1 of its ownK031074 Digital Ambulatory Ecg (Holter) RecorderDatrix · 2003
- Descendant · 4 generations on · 0 of its ownK133014 DMS 300-2W Holter Ecg RecorderDiagnostic Monitoring Software · 2014
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K982975Digital Ecg Holter Recorder, Model DR512Datrix · 1998 · cites it directly5descendants
- K062007DMS 300-7Diagnostic Monitoring Software · 2006 · 2 generations on2descendants
- K062959DMS 300-2, 300-3 and 300-4Diagnostic Monitoring Software · 2006 · 3 generations on1descendant
- K031074Digital Ambulatory Ecg (Holter) RecorderDatrix · 2003 · 2 generations on1descendant
- K133014DMS 300-2W Holter Ecg RecorderDiagnostic Monitoring Software · 2014 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K921068 | Gikter Ecg Cassette Tape Recorder Model XR 300 | Datrix | 1992 | — |
| +1 | K982975 | Digital Ecg Holter Recorder, Model DR512 | Datrix | 1998 | — |
| +2 | K062007 | DMS 300-7 | Diagnostic Monitoring Software | 2006 | — |
| +3 | K062959 | DMS 300-2, 300-3 and 300-4 | Diagnostic Monitoring Software | 2006 | — |
| +2 | K031074 | Digital Ambulatory Ecg (Holter) Recorder | Datrix | 2003 | — |
| +4 | K133014 | DMS 300-2W Holter Ecg Recorder | Diagnostic Monitoring Software | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 2 | 0 |
| 2011 | 1 | 0 |
| 2014 | 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 DSH? 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 DSH device
- #1 K260157 LifeLens Physiological Monitorscore 17.9 · 22 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (7)
2 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, K982975 (Datrix, 1998) has gone furthest, with 5 descendants of its own.
How does its category compare?
All DSH devicesDSH Recorder, Magnetic Tape, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DSH
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DSH
205in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DSH
No recall names DSH since 2007.
Adverse event reports per year · DSH
213in 2025
MAUDE reports naming product code DSH, 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 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 3 | 84 | 0 | 1 |
| 2010 | 2 | — | 0 | 8 |
| 2011 | 6 | 64 | 0 | 3 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 2 | — | 0 | 2 |
| 2014 | 1 | — | 0 | 3 |
| 2015 | 2 | — | 0 | 8 |
| 2016 | 2 | — | 0 | 6 |
| 2017 | 3 | 91 | 0 | 31 |
| 2018 | 3 | 269 | 0 | 30 |
| 2019 | 3 | 30 | 0 | 76 |
| 2020 | 4 | 122 | 0 | 91 |
| 2021 | 4 | 263 | 0 | 113 |
| 2022 | 4 | 427 | 0 | 46 |
| 2023 | 6 | 198 | 0 | 65 |
| 2024 | 2 | — | 0 | 88 |
| 2025 | 4 | 205 | 0 | 213 |
| 2026 | 2 | — | 0 | — |
https://510kreport.com/device/K921068 · printed Nov 6, 2026
Cite this page
510(k) Report. “K921068: Gikter Ecg Cassette Tape Recorder Model XR 300.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K921068
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026