510(k) · Cleared
ClearedSimpleabi
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Newman Medical · JAF Monitor, Ultrasonic, Nonfetal
Cleared on May 12, 2011 as substantially equivalent to K090465 (The Newman Group, LLC, 2009) after a 70-day review. Its family tree reaches back 1 generation to 2009.
- Decided
- May 12, 2011
- Review
- 70 days
- Class
- Class II
- Product code
- JAF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K090465 (2009). No later device cites it as a predicate yet.
- Root · 1 generation backK090465 Digdop Ultrasound SystemThe Newman Group, LLC · 2009
- This deviceK110628 SimpleabiNewman Medical · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K090465 | Digdop Ultrasound System | The Newman Group, LLC | 2009 | — |
| 0 (this device) | K110628 | Simpleabi | Newman Medical | 2011 | — |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JAF? 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 JAF device
- #1 K242487 Laminar P1 (LDH-HW-001)score 10.3 · 7 generations · no Class I recall
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 |
|---|---|---|---|
| * | K090465 | Digdop Ultrasound SystemSummary page 6…__________ N= new Indication; P= previously cleared by FDA; E= added under Appendix E Additional Comments: The nominal 8MHz robe reviouslv submitted and aproved under K090465 _____________________… | 2009 |
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 JAF devicesJAF Monitor, Ultrasonic, Nonfetal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · JAF
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · JAF
Too few JAF 510(k)s in any year since 2007 to give a median.
Recalls per year · JAF
No recall names JAF since 2007.
Adverse event reports per year · JAF
1in 2023
MAUDE reports naming product code JAF, 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 | 2 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 8 |
| 2015 | 1 | — | 0 | 7 |
| 2016 | 0 | — | 0 | 5 |
| 2017 | 0 | — | 0 | 44 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 5 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The simpleABI is a diagnostic ultrasound system used to aid a physician in obtaining systolic pressure values at the arms and legs to aid in the diagnosis of vascular disease. The system utilizes a handheld Doppler for detecting presence or absence of blood flow. The user, using a handheld aneroid, Doppler, and standard blood pressure cuffs, measures the systolic pressures of the arms and legs. Two additional modalities, Pulse Volume Recording (PVR) and…
Read the full statement (164 words)
The simpleABI is a diagnostic ultrasound system used to aid a physician in obtaining systolic pressure values at the arms and legs to aid in the diagnosis of vascular disease. The system utilizes a handheld Doppler for detecting presence or absence of blood flow. The user, using a handheld aneroid, Doppler, and standard blood pressure cuffs, measures the systolic pressures of the arms and legs. Two additional modalities, Pulse Volume Recording (PVR) and Photoplethysmography (PPG), may optionally provide additional Information for the clinician. PVR is used as a plethysmograph to measure the change In limb volume related to each cardiac pulse. The PPG may be used to obtain toe pressures as an optional method if arterial flow using a Doppler Is problematic. The unit will calculate Ankle Brachial index (ABI), Toe Brachial Index (TBI) or segmental values once the clinician has entered the appropriate pressure values read from the handheld aneroid. Waveforms, pressure values, and index results can be printed directly from the system.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K110628 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110628: Simpleabi.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110628
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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