510(k) · Cleared
ClearedNewmed Abp-Lite
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Newmed Corp. · DXW System, Phonocatheter, Intracavitary
Cleared on Sep 5, 1996 as substantially equivalent to K913595 (Koven and Assoc., Inc., 1992) after a 252-day review. Its family tree reaches back 1 generation to 1992.
- Decided
- Sep 5, 1996
- Review
- 252 days
- Class
- Class II
- Product code
- DXW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K913595 (1992). No later device cites it as a predicate yet.
- Root · 1 generation backK913595 DS-240 Ambulatory Blood Pressure Monitoring SystemKoven and Assoc., Inc. · 1992
- This deviceK955887 Newmed Abp-LiteNewmed Corp. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K913595 | DS-240 Ambulatory Blood Pressure Monitoring System | Koven and Assoc., Inc. | 1992 | — |
| 0 (this device) | K955887 | Newmed Abp-Lite | Newmed Corp. | 1996 | — |
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 DXW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K913595 | DS-240 Ambulatory Blood Pressure Monitoring SystemSummary page 1…ive blood pressure measurement system (per 21 C.F.R. § 07.1130) The ABP-lite is substantially equivalent to the Nissei/NewMed ABP 1000i (Koven & Associates -- DS-240 -- K913595). The ABP-lite is a 24-hour Ambulatory Blood Pressure Monitoring System (ABPMS) which obtains and stores the results of repeated… | 1992 |
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.
- 1 other device also cites its predicate K913595.
How does its category compare?
All DXW devicesDXW System, Phonocatheter, Intracavitary: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DXW
FDA has decided no DXW device since 2007.
Median 510(k) review, days · DXW
Too few DXW 510(k)s in any year since 2007 to give a median.
Recalls per year · DXW
No recall names DXW since 2007.
Adverse event reports per year · DXW
No MAUDE report names DXW since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The intended use of the ABP-/ite is to detect, diagnose, and monitor hypertension.
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/K955887 · printed Nov 6, 2026
Cite this page
510(k) Report. “K955887: Newmed Abp-Lite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K955887
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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