510(k) · Cleared
Recalled · Class II · 2018Easy Touch
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mhc Medical Products, LLC · FMI Needle, Hypodermic, Single Lumen
Cleared on Dec 23, 2011 as substantially equivalent to K080904 (Feel Tech, 2008) and 2 other predicates after an 88-day review. Its family tree reaches back 3 generations to 1997. It has been recalled 2 times.
- Decided
- Dec 23, 2011
- Review
- 88 days
- Class
- Class II
- Product code
- FMI
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 3 generations to K973899 (1997). 5 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 |
|---|---|---|---|---|---|
| −3 | K973899 | Unifine Pentips | Owen Mumford USA, Inc. | 1997 | — |
| −2 | K033575 | One.Click Needle | B.Braun Medical, Inc. | 2004 | — |
| −1 | K080904 | Feel-Fine Insulin Pen Needle | Feel Tech | 2008 | 7 |
| 0 (this device) | K112789 | Easy Touch | Mhc Medical Products, LLC | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2010 | 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 FMI? 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 FMI device
- #1 K252886 Pen Needlescore 14.5 · 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? (3)
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 |
|---|---|---|---|
| * | K080904 | Feel-Fine Insulin Pen NeedleSummary page 1…880.5570 Class of device: Class 11. 2. The legally marketed device to which we are claiming equivalence [807.92(a)(3)] Feel Fine insulin pen needle K080904 (Easy.Touch is a relabeled version of this product) as well as K100005 and K(051899 Becton Dickenson Pen Needles. 3.… | 2008 |
| * | K100005 | BD Pen NeedleSummary page 1…e to which we are claiming equivalence [807.92(a)(3)] Feel Fine insulin pen needle K080904 (Easy.Touch is a relabeled version of this product) as well as K100005 and K(051899 Becton Dickenson Pen Needles. 3. Description of device: The Pen Needle consists of a sterile cap, needle cap… | 2010 |
| * | K051899 | BD Pen NeedleSummary page 1…are claiming equivalence [807.92(a)(3)] Feel Fine insulin pen needle K080904 (Easy.Touch is a relabeled version of this product) as well as K100005 and K(051899 Becton Dickenson Pen Needles. 3. Description of device: The Pen Needle consists of a sterile cap, needle cap needle huh,… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 6, 2018 | Class II | Z-1780-2018 | Labeling mix-ups | The retail shelf cartons may be labeled with an incorrect lot number. |
| Apr 6, 2018 | Class II | Z-1779-2018 | Labeling mix-ups | The retail shelf cartons may be labeled with an incorrect lot number. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 4 companies; a new generation was cleared every 4.3 years on median.
- 1 of the 5 ancestors has a recall of any class.
- 7 other devices also cite its predicate K080904.
How does its category compare?
All FMI devicesFMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · FMI
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FMI
141in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FMI
1in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · FMI
2,424in 2025
MAUDE reports naming product code FMI, 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 | 15 | 71 | 2 | 208 |
| 2008 | 10 | 85 | 4 | 177 |
| 2009 | 7 | 177 | 3 | 263 |
| 2010 | 15 | 119 | 79 | 249 |
| 2011 | 12 | 113 | 5 | 240 |
| 2012 | 17 | 107 | 1 | 215 |
| 2013 | 11 | 87 | 1 | 255 |
| 2014 | 14 | 155 | 3 | 287 |
| 2015 | 10 | 89 | 1 | 567 |
| 2016 | 20 | 217 | 0 | 941 |
| 2017 | 9 | 253 | 16 | 1,547 |
| 2018 | 20 | 176 | 0 | 2,398 |
| 2019 | 12 | 186 | 5 | 4,896 |
| 2020 | 11 | 263 | 3 | 4,245 |
| 2021 | 18 | 143 | 7 | 4,532 |
| 2022 | 23 | 189 | 0 | 4,885 |
| 2023 | 18 | 112 | 2 | 4,986 |
| 2024 | 3 | 90 | 1 | 4,053 |
| 2025 | 11 | 141 | 0 | 2,424 |
| 2026 | 12 | 119 | 1 (1) | — |
What is it indicated for?
These disposable sterile insulin pen needles are intended for subcutaneous injection of insulin in the treatment of diabetes
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112789 · printed Nov 4, 2026
Cite this page
510(k) Report. “K112789: Easy Touch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K112789
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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