510(k) · Cleared
ClearedSkin Dose Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mcmahon Medical · OWB Interventional Fluoroscopic X-Ray System
Cleared on Sep 5, 1996 after a 169-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Sep 5, 1996
- Review
- 169 days
- Class
- Class II
- Product code
- OWB
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK961105 Skin Dose MonitorMcmahon Medical · 1996
- Descendant · cites it directly · 0 of its ownK042698 Unfors Patient Skin Dosimeter (PSD)Unfors, Inc. · 2004
Most influential descendants
Showing 1 of 1 · See all- K042698Unfors Patient Skin Dosimeter (PSD)Unfors, Inc. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K961105 | Skin Dose Monitor | Mcmahon Medical | 1996 | — |
| +1 | K042698 | Unfors Patient Skin Dosimeter (PSD) | Unfors, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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 OWB? 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 OWB device
- #1 K251602 Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6…score 18.3 · 18 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 |
|---|---|---|---|
| * | — | In Vivo Dosimeter Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042698 | Unfors Patient Skin Dosimeter (PSD) | 2004 | 0 |
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?
- Of its descendants, K042698 (Unfors, Inc., 2004) has gone furthest, with 0 descendants of its own.
How does its category compare?
All OWB devicesOWB Interventional Fluoroscopic X-Ray System: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OWB
22in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OWB
148in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OWB
42so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OWB
14,008in 2025
MAUDE reports naming product code OWB, 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 | 3 | 52 | 0 | 1 |
| 2008 | 4 | 135 | 1 | 0 |
| 2009 | 9 | 99 | 0 | 0 |
| 2010 | 7 | 66 | 0 | 0 |
| 2011 | 6 | 79 | 0 | 1 |
| 2012 | 6 | 37 | 0 | 1 |
| 2013 | 11 | 119 | 10 | 27 |
| 2014 | 15 | 158 | 9 | 103 |
| 2015 | 11 | 66 | 35 | 2,134 |
| 2016 | 16 | 103 | 13 | 4,074 |
| 2017 | 20 | 76 | 13 | 1,604 |
| 2018 | 23 | 54 | 6 | 1,449 |
| 2019 | 9 | 174 | 7 | 1,558 |
| 2020 | 16 | 53 | 8 | 1,581 |
| 2021 | 24 | 60 | 31 | 1,981 |
| 2022 | 21 | 90 | 24 | 2,932 |
| 2023 | 12 | 152 | 22 | 7,604 |
| 2024 | 13 | 126 | 11 | 7,942 |
| 2025 | 22 | 148 | 30 | 14,008 |
| 2026 | 15 | 221 | 42 | — |
What is it indicated for?
Although intended primarily for use during Radiological Interventional and Special Procedures, the Skin Dose Monitor can be used whenever there is an interest in knowing patient skin‘dose. The primary purpose of the product is to monitor beam entry skin dose within the radiation beam, where there may be a risk of skin burns or cancers du~ to extremely high doses. In these situations the beam direction is fixed for a major part of the procedure and the…
Read the full statement (273 words)
Although intended primarily for use during Radiological Interventional and Special Procedures, the Skin Dose Monitor can be used whenever there is an interest in knowing patient skin‘dose. The primary purpose of the product is to monitor beam entry skin dose within the radiation beam, where there may be a risk of skin burns or cancers du~ to extremely high doses.
In these situations the beam direction is fixed for a major part of the procedure and the sensor siting is obvious.
If the Skin Dose Monitor is to be used for other applications such as dose monitoring of a pregnant woman during general radiological procedures or monitoring doses during fluoroscopic guided surgery, the sensor site may be less obvious. Under these circumstances the sensor might be mounted on the X-Ray collimator face.
The real time display of dose may be used to indicate the need to take action to avoid excessive dose to one area of skin by changing the beam direction. The rate indicating LED provides a means to take action which will keep dosage per minute during fluoroscopy at the minimum level needed to ensure acceptable images.
The Skin Dose Monitor is also an effective tool for use during staff training or when benchmark protocols are being established for new procedures.
Contra indications for use are when the radiation energy or doserate being used fall outside the Skin Dose Monitor's specification, or where the small artefact ¢ "he image (1 sq. mm), due to the sensor, is unacceptable.
‘. attention is drawn to the user for the need to gas sterilize sensors between applications in accordance with local infection control practice.
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/K961105 · printed Nov 6, 2026
Cite this page
510(k) Report. “K961105: Skin Dose Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K961105
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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