510(k) · Cleared
ClearedTebco-W
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bomed, Inc. · DXG Computer, Diagnostic, Pre-Programmed, Single-Function
Cleared on Aug 1, 2014 as substantially equivalent to K962128 (Hemo Sapiens, Inc., 1996) after a 319-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Aug 1, 2014
- Review
- 319 days
- Class
- Class II
- Product code
- DXG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K962128 (1996). No later device cites it as a predicate yet.
- Root · 1 generation backK962128 Tebco (Thoracic Electrical Bioimpedance Cardiac Output)Hemo Sapiens, Inc. · 1996
- This deviceK132892 Tebco-WBomed, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K962128 | Tebco (Thoracic Electrical Bioimpedance Cardiac Output) | Hemo Sapiens, Inc. | 1996 | — |
| 0 (this device) | K132892 | Tebco-W | Bomed, Inc. | 2014 | — |
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 DXG? 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 DXG device
- #1 K253092 Argos Infinity (Rev. 1.0)score 11.1 · 2 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 |
|---|---|---|---|
| * | K962128 | Tebco (Thoracic Electrical Bioimpedance Cardiac Output)Summary page 5…equivalency is claimed The Predicate Device: TEBCO Manufacturer: HEMO SAPINES INC. Predicate Device K#: K962128 21 CFR 807.92(a) (4): Description of the Device that is the subject of this… | 1996 |
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 DXG devicesDXG Computer, Diagnostic, Pre-Programmed, Single-Function: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · DXG
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXG
290in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXG
2in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXG
8in 2025
MAUDE reports naming product code DXG, 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 | — | 1 | 43 |
| 2008 | 5 | 118 | 1 | 37 |
| 2009 | 0 | — | 6 | 8 |
| 2010 | 4 | 282 | 1 | 17 |
| 2011 | 3 | 104 | 0 | 7 |
| 2012 | 2 | — | 0 | 29 |
| 2013 | 3 | 236 | 0 | 23 |
| 2014 | 6 | 290 | 0 | 44 |
| 2015 | 1 | — | 0 | 34 |
| 2016 | 1 | — | 0 | 67 |
| 2017 | 1 | — | 0 | 62 |
| 2018 | 2 | — | 0 | 83 |
| 2019 | 2 | — | 0 | 81 |
| 2020 | 1 | — | 2 | 49 |
| 2021 | 1 | — | 0 | 29 |
| 2022 | 0 | — | 0 | 44 |
| 2023 | 1 | — | 0 | 12 |
| 2024 | 0 | — | 0 | 21 |
| 2025 | 1 | — | 0 | 8 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Adults, Hospital, Cardiology, Internal medicine
TEBCO-W is indicated for noninvasive, continuous assessment and monitoring of the
left-ventricular performance and global blood flow (Stroke Index, SI and Cardiac Index,
CI) in adults, where use of invasive catheters is contraindicated.
The device may be used only on the order of a physician and is ”By prescription only.”
The intended use is physician’s office and cardiovascular physiology laboratory.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132892 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132892: Tebco-W.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132892
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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