510(k) · Cleared
Recalled · 2010Disp. Hypodermic Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Terumo America, Inc. · FMI Needle, Hypodermic, Single Lumen
Cleared on Jul 14, 1977 after a 9-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 98 later devices descend from it. It has been recalled once.
- Decided
- Jul 14, 1977
- Review
- 9 days
- Class
- Class II
- Product code
- FMI
- Recalls
- 1
- Predicates
- 0
98 later devices descend from it, 8 citing it directly.
- This deviceK771203 Disp. Hypodermic NeedleTerumo America, Inc. · 1977
- Descendant · cites it directly · 83 of its ownK012646 Terumo 30 Gauge Hypodermic NeedleTerumo Medical Corp. · 2001
- Descendant · cites it directly · 74 of its ownK031453 Terumo Surguard 2 Safety NeedleTerumo Medical Corp. · 2003
- Descendant · cites it directly · 67 of its ownK040531 Terumo SURGUARD2 Safety NeedleTerumo Medical Corp. · 2004
- Descendant · 2 generations on · 65 of its ownK051865 Terumo Surguard 2 Safety Needle or SimilarTerumo Medical Corp. · 2005
- Descendant · 3 generations on · 60 of its ownK113422 Terumo Surguard 3 Safety Needle Terumo Surguard 3 Hypodermic Syringe…Terumo (Philippines) Corporation · 2012
Showing 5 of 98 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 98 · See all- K012646Terumo 30 Gauge Hypodermic NeedleTerumo Medical Corp. · 2001 · cites it directly83descendants
- K031453Terumo Surguard 2 Safety NeedleTerumo Medical Corp. · 2003 · cites it directly74descendants
- K040531Terumo SURGUARD2 Safety NeedleTerumo Medical Corp. · 2004 · cites it directly67descendants
- K051865Terumo Surguard 2 Safety Needle or SimilarTerumo Medical Corp. · 2005 · 2 generations on65descendants
- K113422Terumo Surguard 3 Safety Needle Terumo Surguard 3 Hypodermic Syringe with Safety NeedleTerumo (Philippines) Corporation · 2012 · 3 generations on60descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K771203 | Disp. Hypodermic Needle | Terumo America, Inc. | 1977 | — |
| +1 | K012646 | Terumo 30 Gauge Hypodermic Needle | Terumo Medical Corp. | 2001 | — |
| +1 | K031453 | Terumo Surguard 2 Safety Needle | Terumo Medical Corp. | 2003 | — |
| +1 | K040531 | Terumo SURGUARD2 Safety Needle | Terumo Medical Corp. | 2004 | — |
| +2 | K051865 | Terumo Surguard 2 Safety Needle or Similar | Terumo Medical Corp. | 2005 | — |
| +3 | K113422 | Terumo Surguard 3 Safety Needle Terumo Surguard 3 Hypodermic Syringe with… | Terumo (Philippines) Corporation | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 4 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 5 | 0 |
| 2013 | 2 | 0 |
| 2015 | 4 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 4 | 0 |
| 2021 | 7 | 0 |
| 2022 | 20 | 0 |
| 2023 | 9 | 0 |
| 2024 | 9 | 0 |
| 2025 | 7 | 0 |
| 2026 | 6 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (98)
See all 988 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K012646 | Terumo 30 Gauge Hypodermic Needle | 2001 | 83 |
| K031453 | Terumo Surguard 2 Safety Needle | 2003 | 74 |
| K040531 | Terumo SURGUARD2 Safety Needle | 2004 | 67 |
| K984576 | K-Pack II (Hypodermic Needle) 23G X 1, Model KN-2325RB, K-Pack II Needle (Hypodermic… | 1999 | 13 |
| K052445 | Duopross Needle | 2005 | 1 |
| K121607 | Terumo (R) Needle | 2012 | 0 |
| K121270 | Bioject Needle-Free Injection Management System | 2012 | 0 |
| K953940 | Terumo Retractable Needle (RN) Syringe | 1996 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 8, 2010 | Not classified | Z-2798-2011 | Packaging | Hypodermic needle packaging defect could compromise sterility. Affected lot numbers are: MC1725, MC2025, MC2025 |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K012646 (Terumo Medical Corp., 2001) has gone furthest, with 83 descendants of its own.
How does its category compare?
All FMI devicesFMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years.
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) | — |
https://510kreport.com/device/K771203 · printed Nov 6, 2026
Cite this page
510(k) Report. “K771203: Disp. Hypodermic Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K771203
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026