510(k) · Cleared
ClearedThe Addition
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ob The-Addition, LLC · MUI Media, Coupling, Ultrasound
Cleared on Jan 6, 2011 as substantially equivalent to K031894 (Sonotech, Inc., 2003) and 1 other predicate after a 111-day review. Its family tree reaches back 2 generations to 1980.
- Decided
- Jan 6, 2011
- Review
- 111 days
- Class
- Class II
- Product code
- MUI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K802146 (1980). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K802146 | Aquasonic 100 Ultrasound Trans. Gel, | Parker Laboratories, Inc. | 1980 | 1 |
| −1 | K072515 | Embrace Gel | Orison Corporation | 2007 | — |
| 0 (this device) | K102683 | The Addition | Ob The-Addition, LLC | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 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 MUI? 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 MUI device
- #1 K253255 Non-Sterile Ultrasound Gel Sterile Ultrasound…score 12.4 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K031894 | Scantec PadSummary page 1…transducer, 21 CFR, 892.1570 NAME: DEVICE Class 11 CLASSIFICATION: PRODUCT CODE MUI PREDICATE DEVICES: ScanTec Pad K03 1894 Embrace Gel Pad K072515 Substantially Equivalent To: The-Addition is substantially equivalent in in… | 2003 |
| * | K072515 | Embrace GelSummary page 1…Class 11 CLASSIFICATION: PRODUCT CODE MUI PREDICATE DEVICES: ScanTec Pad K03 1894 Embrace Gel Pad K072515 Substantially Equivalent To: The-Addition is substantially equivalent in intended use, principal of operation and technological… | 2007 |
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?
- The line of descent spans 31 years and passes through 3 companies; a new generation was cleared every 26.9 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 1 other device also cites its predicate K031894.
How does its category compare?
All MUI devicesMUI Media, Coupling, Ultrasound: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · MUI
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MUI
434in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MUI
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MUI
25in 2025
MAUDE reports naming product code MUI, 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 | 0 | — | 0 | 2 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 6 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 2 | — | 2 | 1 |
| 2013 | 2 | — | 0 | 1 |
| 2014 | 1 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 5 | 434 | 0 | 2 |
| 2019 | 1 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 1 | — | 0 | 13 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 1 | — | 1 | 2 |
| 2024 | 2 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 25 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The-Addition provides padding for patient comfort and aids in the retention of
coupling media in a defined position.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102683 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102683: The Addition.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102683
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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