510(k) · Cleared

Cleared

Terumo 30 Gauge Hypodermic Needle

K012646510(k) SpecialCleared Aug 27, 200114-day reviewClass II21 CFR 880.5570

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Terumo Medical Corp. · FMI Needle, Hypodermic, Single Lumen

Cleared on Aug 27, 2001 as substantially equivalent to K771203 (Terumo America, Inc., 1977) after a 14-day review. Its family tree reaches back 1 generation to 1977. 83 later devices descend from it.

Decided: Aug 27, 2001
Review: 14 days
Class: Class II
Product code: FMI
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K771203 (1977). 83 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 1 generation backK771203 Disp. Hypodermic NeedleTerumo America, Inc. · 1977 · Recalled
This deviceK012646 Terumo 30 Gauge Hypodermic NeedleTerumo Medical Corp. · 2001
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
Descendant · 4 generations on · 32 of its ownK170651 Sterile Disposable Syringe with Safety Needle, Sterile Disposable…Yangzhou Medline Industry, Co., Ltd. · 2017
Descendant · 5 generations on · 14 of its ownK192551 1ml Luer Slip or Luer Lock Syringe, Syringe with permanently…Jiangsu Caina Medical Co.,Ltd · 2020

Showing 5 of 83 descendants. See all descendants

Descendants cleared per year

2002high 20 (2022) · low 0 (2003)2026

Most influential descendants

Showing 5 of 83 · See all

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
K170651Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle…Yangzhou Medline Industry, Co., Ltd. · 2017 · 4 generations on32descendants
K1925511ml Luer Slip or Luer Lock Syringe, Syringe with permanently attached needle, Safety…Jiangsu Caina Medical Co.,Ltd · 2020 · 5 generations on14descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K771203	Disp. Hypodermic Needle	Terumo America, Inc.	1977	1
0 (this device)	K012646	Terumo 30 Gauge Hypodermic Needle	Terumo Medical Corp.	2001	—
+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	—
+4	K170651	Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with…	Yangzhou Medline Industry, Co., Ltd.	2017	—
+5	K192551	1ml Luer Slip or Luer Lock Syringe, Syringe with permanently attached needle…	Jiangsu Caina Medical Co.,Ltd	2020	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2004	1	0
2005	2	0
2006	1	0
2007	1	0
2008	1	0
2009	1	0
2011	3	0
2012	3	0
2013	2	0
2015	3	0
2017	1	0
2018	1	0
2019	3	0
2020	4	0
2021	6	0
2022	20	0
2023	9	0
2024	7	0
2025	7	0
2026	6	0

FIG. 1 — Lineage of K012646, 1977–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K771203	Disp. Hypodermic Needle Summary page 1 …c Needle Classification Name: Needle, Hypodermic, Single Lumen B. Reason for Submission: This 510k is being submitted to extend the cleared Terumo Hypodermic Needle* (K771203) product line. (*also referred to as the standard Terumo needle.) The size of the 30g needle is smaller than what is currently cl…	Terumo America, Inc.	1977	1
*	—	BD 30 Gauge (Precision Glide) Hypodermic Needle Named without a submission number			—

Also cleared against K771203: 7 other devices →

What descends from it? (83)

See all 83

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K040531	Terumo SURGUARD2 Safety Needle	Terumo Medical Corp.	2004	67
K062608	29G and 30G K-Pack II Needle	Terumo Europe N.V.	2006	10
K021224	Endocervical Block Needle	Wallach Surgical Devices, Inc.	2002	1
K121607	Terumo (R) Needle	Terumo (Philippines) Corporation	2012	0
K073122	Monoject Hypodermic Needle, Model 250, 30 Gauge Hypodermic Needle	Covidien Lp, Formerly Registered AS Tyco Healthcar	2007	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?

Its one ancestor has a recall.
Of its descendants, K040531 (Terumo Medical Corp., 2004) has gone furthest, with 67 descendants of its own.
7 other devices also cite its predicate K771203.

How does its category compare?

All FMI devices

FMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FMI

11in 2025

2007high 23 (2022) · low 3 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FMI

141in 2025

2007high 263 (2020) · low 71 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FMI

1in 2024

2007high 79 (2010) · low 0 (2016)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · FMI

2,424in 2025

2007high 4,986 (2023) · low 177 (2008)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?

The TERUMO® 30 gauge hypodermic needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. It is intended to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.

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/K012646 · printed Nov 5, 2026

Cite this page

510(k) Report. “K012646: Terumo 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/K012646

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026