510(k) · Cleared
ClearedProtection Plus Earloop Procedure Mask
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Safety-Med Products, Inc. · FXX Mask, Surgical
Cleared on Dec 17, 2004 after an 80-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 37 later devices descend from it.
- Decided
- Dec 17, 2004
- Review
- 80 days
- Class
- Class II
- Product code
- FXX
- Recalls
- None
- Predicates
- 0
37 later devices descend from it, 1 citing it directly.
- This deviceK042654 Protection Plus Earloop Procedure MaskSafety-Med Products, Inc. · 2004
- Descendant · cites it directly · 36 of its ownK112440 AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd. · 2012
- Descendant · 2 generations on · 25 of its ownK132125 A.B. Dental Devices Dental Implants SystemA.B. Dental Devices, Ltd. · 2014
- Descendant · 2 generations on · 14 of its ownK140440 Noris Medical Dental Implants SystemNoris Medical, Ltd. · 2014
- Descendant · 3 generations on · 7 of its ownK151909 Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd. · 2016
- Descendant · 2 generations on · 6 of its ownK140728 Mpi - Molecular Precision Implant, Cpi - Cylindrical Precision…Ditron Precision, Ltd. · 2014
Showing 5 of 37 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 37 · See all- K112440AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd. · 2012 · cites it directly36descendants
- K132125A.B. Dental Devices Dental Implants SystemA.B. Dental Devices, Ltd. · 2014 · 2 generations on25descendants
- K140440Noris Medical Dental Implants SystemNoris Medical, Ltd. · 2014 · 2 generations on14descendants
- K151909Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd. · 2016 · 3 generations on7descendants
- K140728Mpi - Molecular Precision Implant, Cpi - Cylindrical Precision Implant, Opi - One Piece…Ditron Precision, Ltd. · 2014 · 2 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K042654 | Protection Plus Earloop Procedure Mask | Safety-Med Products, Inc. | 2004 | — |
| +1 | K112440 | AB Dental Devices Implants and Accessories | A.B. Dental Devices, Ltd. | 2012 | — |
| +2 | K132125 | A.B. Dental Devices Dental Implants System | A.B. Dental Devices, Ltd. | 2014 | — |
| +2 | K140440 | Noris Medical Dental Implants System | Noris Medical, Ltd. | 2014 | — |
| +3 | K151909 | Noris Medical Zygomatic Dental Implant System | Noris Medical, Ltd. | 2016 | — |
| +2 | K140728 | Mpi - Molecular Precision Implant, Cpi - Cylindrical Precision Implant, Opi -… | Ditron Precision, Ltd. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 4 | 0 |
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 4 | 0 |
| 2024 | 5 | 0 |
| 2025 | 1 | 0 |
| 2026 | 4 | 0 |
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 FXX? 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 FXX device
- #1 K201479 DemeMASKscore 40.2 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (37)
See all 371 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112440 | AB Dental Devices Implants and Accessories | 2012 | 36 |
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, K112440 (A.B. Dental Devices, Ltd., 2012) has gone furthest, with 36 descendants of its own.
How does its category compare?
All FXX devicesFXX Mask, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FXX
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FXX
123in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FXX
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FXX
11in 2025
MAUDE reports naming product code FXX, 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 | 2 | — | 0 | 11 |
| 2008 | 2 | — | 0 | 10 |
| 2009 | 1 | — | 0 | 3 |
| 2010 | 7 | 144 | 0 | 9 |
| 2011 | 6 | 137 | 0 | 8 |
| 2012 | 1 | — | 0 | 22 |
| 2013 | 3 | 219 | 0 | 9 |
| 2014 | 1 | — | 0 | 5 |
| 2015 | 5 | 298 | 0 | 14 |
| 2016 | 5 | 268 | 0 | 16 |
| 2017 | 1 | — | 0 | 45 |
| 2018 | 3 | 119 | 0 | 21 |
| 2019 | 4 | 124 | 2 | 23 |
| 2020 | 27 | 113 | 0 | 60 |
| 2021 | 218 | 162 | 0 | 67 |
| 2022 | 91 | 113 | 0 | 21 |
| 2023 | 22 | 139 | 1 | 21 |
| 2024 | 15 | 263 | 2 | 21 |
| 2025 | 6 | 123 | 0 | 11 |
| 2026 | 5 | 142 | 0 | — |
What is it indicated for?
This product is intended to be worn by operating room personnel to protect both the surgical patient and the operating room personnel from the transfer of microorganisms, body fluids and particulate material.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K042654 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042654: Protection Plus Earloop Procedure Mask.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042654
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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