510(k) · Cleared
ClearedPenrith Elettra Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Penrith Corporation · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Nov 19, 2010 as substantially equivalent to K022567 (Acuson Corp., 2002) and 2 other predicates after a 261-day review. Its family tree reaches back 6 generations to 1994. 64 later devices descend from it.
- Decided
- Nov 19, 2010
- Review
- 261 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K934041 (1994). 36 ancestors in all, the oldest K894277 (1989). 64 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK934041 Hewlett Packard Conos Ultrasound Imaging System ModificationHewlett-Packard Co. · 1994
- 5 generations backK964309 Sonos 2000, Sonos 2500 (M2406 a)Hewlett-Packard Co. · 1997
- 4 generations backK982800 Ecton Lynx Ultrasound SystemEcton, Inc. · 1998
- 3 generations backK021497 Cypress Ultrasound SystemAcuson Corp. · 2002 · Recalled
- 2 generations backK042055 Cypress Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 1 generation backK052331 Acuson Cypress Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005
- This deviceK100598 Penrith Elettra Ultrasound SystemPenrith Corporation · 2010
- Descendant · cites it directly · 33 of its ownK151339 SONON Ultrasound Imaging System (Model: SONON 300C)Healcerion Co., Ltd. · 2015
- Descendant · cites it directly · 29 of its ownK162417 Acuson Freestyle Ultrasound SystemSiemens Medi Cal Solutions, Inc. · 2016
- Descendant · 2 generations on · 28 of its ownK163138 Clarius Ultrasound SystemClarius Mobile Health Corp. · 2016
- Descendant · 2 generations on · 27 of its ownK163396 ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2017
- Descendant · 3 generations on · 25 of its ownK180039 ACUSON P600 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2018
Showing 5 of 64 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 64 · See all- K151339SONON Ultrasound Imaging System (Model: SONON 300C)Healcerion Co., Ltd. · 2015 · cites it directly33descendants
- K162417Acuson Freestyle Ultrasound SystemSiemens Medi Cal Solutions, Inc. · 2016 · cites it directly29descendants
- K163138Clarius Ultrasound SystemClarius Mobile Health Corp. · 2016 · 2 generations on28descendants
- K163396ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2017 · 2 generations on27descendants
- K180039ACUSON P600 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2018 · 3 generations on25descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K934041 | Hewlett Packard Conos Ultrasound Imaging System Modification | Hewlett-Packard Co. | 1994 | — |
| −5 | K964309 | Sonos 2000, Sonos 2500 (M2406 a) | Hewlett-Packard Co. | 1997 | — |
| −4 | K982800 | Ecton Lynx Ultrasound System | Ecton, Inc. | 1998 | — |
| −3 | K021497 | Cypress Ultrasound System | Acuson Corp. | 2002 | 2 |
| −2 | K042055 | Cypress Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −1 | K052331 | Acuson Cypress Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | — |
| 0 (this device) | K100598 | Penrith Elettra Ultrasound System | Penrith Corporation | 2010 | — |
| +1 | K151339 | SONON Ultrasound Imaging System (Model: SONON 300C) | Healcerion Co., Ltd. | 2015 | — |
| +1 | K162417 | Acuson Freestyle Ultrasound System | Siemens Medi Cal Solutions, Inc. | 2016 | — |
| +2 | K163138 | Clarius Ultrasound System | Clarius Mobile Health Corp. | 2016 | — |
| +2 | K163396 | ACUSON P500 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2017 | — |
| +3 | K180039 | ACUSON P600 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 3 | 0 |
| 1994 | 3 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 5 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 4 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 5 | 0 |
| 2021 | 6 | 0 |
| 2022 | 12 | 0 |
| 2023 | 6 | 0 |
| 2024 | 8 | 0 |
| 2025 | 8 | 0 |
| 2026 | 7 | 0 |
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 IYN? 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 IYN device
- #1 K240850 EPIQ Series Diagnostic Ultrasound Systems…score 32.1 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K022567 | Sequoia Signature II Diagnostic Ultrasound SystemSummary page 2…Musculoskeletal (Conventional), and Musculoskeletal (Superficial). The Company believes that the Penrith Elettra is substantially equivalent to the Acuson Sequoia, K(022567, the Acuson Cypress K052331, and the Philips Avalon CTS, K023931. The Penrith Elettra system and transducers function in a m… | 2002 |
| * | K052331 | Acuson Cypress Ultrasound SystemSummary page 2…al), and Musculoskeletal (Superficial). The Company believes that the Penrith Elettra is substantially equivalent to the Acuson Sequoia, K(022567, the Acuson Cypress K052331, and the Philips Avalon CTS, K023931. The Penrith Elettra system and transducers function in a manner that is substantially… | 2005 |
| * | K023931 | Philips Avalon CTS Cordless Fetal Transducer System, Models M2720A, M2725A, M2726A, M2727ASummary page 2…). The Company believes that the Penrith Elettra is substantially equivalent to the Acuson Sequoia, K(022567, the Acuson Cypress K052331, and the Philips Avalon CTS, K023931. The Penrith Elettra system and transducers function in a manner that is substantially equivalent to the previously cleared… | 2003 |
What descends from it? (64)
See all 643 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?
- The line of descent spans 16 years and passes through 5 companies; a new generation was cleared every 2.6 years on median.
- 3 of the 36 ancestors have a recall of any class.
- Of its descendants, K151339 (Healcerion Co., Ltd., 2015) has gone furthest, with 33 descendants of its own.
- 9 other devices also cite its predicate K022567.
How does its category compare?
All IYN devicesIYN System, Imaging, Pulsed Doppler, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · IYN
57in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYN
124in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYN
10in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · IYN
610in 2025
MAUDE reports naming product code IYN, 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 | 13 | 26 | 16 | 3 |
| 2008 | 25 | 18 | 12 | 2 |
| 2009 | 18 | 29 | 8 | 9 |
| 2010 | 29 | 67 | 10 | 17 |
| 2011 | 39 | 46 | 8 | 18 |
| 2012 | 43 | 37 | 3 | 20 |
| 2013 | 51 | 60 | 8 | 18 |
| 2014 | 56 | 39 | 2 | 48 |
| 2015 | 54 | 55 | 3 | 116 |
| 2016 | 60 | 56 | 2 | 145 |
| 2017 | 64 | 83 | 0 | 146 |
| 2018 | 59 | 85 | 7 | 85 |
| 2019 | 47 | 79 | 0 | 59 |
| 2020 | 57 | 72 | 4 | 67 |
| 2021 | 46 | 105 | 8 | 213 |
| 2022 | 53 | 105 | 10 | 186 |
| 2023 | 44 | 115 | 4 | 229 |
| 2024 | 50 | 119 | 1 | 266 |
| 2025 | 57 | 124 | 10 | 610 |
| 2026 | 44 | 107 | 2 (1) | — |
What is it indicated for?
The Elettra Ultrasound System is intended for diagnostic imaging or fluid flow analysis of the human body including: Fetal, Abdominal, Intraoperative, Intraoperative Neurological, Pediatric, Small Organ, Neonatal Cephalic, Cardiac, Peripheral Vessel, Musculoskeletal (Conventional), Musculoskeletal (Superficial).
Diagnostic Imaging or fluid flow analysis of the human body as follows:
Diagnostic Imaging or fluid flow analysis of the human body as follows:
Diagnostic Imaging or fluid flow analysis of the human body as follows:
Diagnostic Imaging or fluid flow analysis of the human body as follows:
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100598 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100598: Penrith Elettra Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100598
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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