510(k) · Cleared
ClearedOmnicorder, Model 464
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Del Mar Avionics · DSH Recorder, Magnetic Tape, Medical
Cleared on Feb 9, 1999 as substantially equivalent to K950020 (Del Mar Avionics, 1995) after a 35-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Feb 9, 1999
- Review
- 35 days
- Class
- Class II
- Product code
- DSH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K950020 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK950020 Holter Pacercorder (R)Del Mar Avionics · 1995
- This deviceK990027 Omnicorder, Model 464Del Mar Avionics · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K950020 | Holter Pacercorder (R) | Del Mar Avionics | 1995 | — |
| 0 (this device) | K990027 | Omnicorder, Model 464 | Del Mar Avionics | 1999 | — |
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 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? (1)
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 |
|---|---|---|---|
| * | K950020 | Holter Pacercorder (R)Summary page 1…00 Raphael Henkin December 31, 1998 Model 464 OmniCorder™ Holter Cassette Recorder Medical Magnetic Tape Recorder (21 CFR §870.2800) Model 461 Pacercorder® 510(k) #K950020 The Model 464 OmniCorder™ is a compact Holter ECG magnetic tape recorder utilizing standard C60 and C90 cassettes. The recorder… | 1995 |
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?
- Its one ancestor has no recall.
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 | — |
What is it indicated for?
The Del Mar Avionics Model 464 DigiCorder™ is a 3-channel ECG analog cassette tape recorder. By an operator settable dip switches the recorder will perform either conventional 3-channel ECG recording or pacemaker detection recording 2 channels of ECG and 1 channel of “pseudo” pacemaker pulses each time the patient’s implanted pacemaker produces a detectable pulse. A second operator selectable dip switch allows selection of recording speed at 0.5 mm/S, 1.0 mm/S or 1.5 mm/S.
The Del Mar Avionics Model 464 OmniCorder™ is intended for use as a Holter ECG cardiac-monitoring tool.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K990027 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990027: Omnicorder, Model 464.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990027
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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