510(k) · Cleared
ClearedMonoject Hypodermic Needle, Model 250, 30 Gauge Hypodermic Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien Lp, Formerly Registered AS Tyco Healthcar · FMI Needle, Hypodermic, Single Lumen
Cleared on Nov 21, 2007 as substantially equivalent to K854547 (Sherwood Medical Co., 1986) and 1 other predicate after a 15-day review. Its family tree reaches back 2 generations to 1977.
- Decided
- Nov 21, 2007
- Review
- 15 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K771203 (1977). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK771203 Disp. Hypodermic NeedleTerumo America, Inc. · 1977 · Recalled
- 1 generation backK012646 Terumo 30 Gauge Hypodermic NeedleTerumo Medical Corp. · 2001
- This deviceK073122 Monoject Hypodermic Needle, Model 250, 30 Gauge Hypodermic NeedleCovidien Lp, Formerly Registered AS Tyco Healthcar · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K771203 | Disp. Hypodermic Needle | Terumo America, Inc. | 1977 | 1 |
| −1 | K012646 | Terumo 30 Gauge Hypodermic Needle | Terumo Medical Corp. | 2001 | — |
| 0 (this device) | K073122 | Monoject Hypodermic Needle, Model 250, 30 Gauge Hypodermic Needle | Covidien Lp, Formerly Registered AS Tyco Healthcar | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 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? (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 |
|---|---|---|---|
| * | K854547 | Monoject Sterile M200 Aluminum/M250 PolypropyleneSummary page 1…880.5570 Classification Panel: General Hospital Legally Marketed Devices to Which Substantial Equivalence Is Claimed: * MONOJECT® Sterile M250 Hypodermic Needles, K854547 TERUMO®30 Gauge Hypodermic Needle, K012646 Device Intended Use: The proposed devices are intended for the injection of… | 1986 |
| * | K012646 | Terumo 30 Gauge Hypodermic NeedleSummary page 1…Legally Marketed Devices to Which Substantial Equivalence Is Claimed: * MONOJECT® Sterile M250 Hypodermic Needles, K854547 TERUMO®30 Gauge Hypodermic Needle, K012646 Device Intended Use: The proposed devices are intended for the injection of medications into or the withdrawal of body fluids… | 2001 |
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 30 years and passes through 3 companies; a new generation was cleared every 24.1 years on median.
- 2 of the 3 ancestors have a recall of any class.
- 2 other devices also cite its predicate K854547.
How does its category compare?
All FMI devicesFMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 devices are intended for the injection of medications into or the withdrawal of body fluids from parts of the body below the surface of the skin.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073122 · printed Nov 5, 2026
Cite this page
510(k) Report. “K073122: Monoject Hypodermic Needle, Model 250, 30 Gauge Hypodermic Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K073122
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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