510(k) · Cleared

Cleared

Inviro Snap Safety Syringe, 1CC, 3CC, 5CC, and 10CC

K032780510(k) SpecialCleared Sep 24, 200316-day reviewClass II21 CFR 880.5860

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

Cleared on Sep 24, 2003 as substantially equivalent to K941450 (Dr. F. Ross Sharp, Ltd., 1994) after a 16-day review. Its family tree reaches back 1 generation to 1994. 10 later devices descend from it.

Decided: Sep 24, 2003
Review: 16 days
Class: Class II
Product code: MEG
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K941450 (1994). 10 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK941450 Inviro SyringeDr. F. Ross Sharp, Ltd. · 1994
This deviceK032780 Inviro Snap Safety Syringe, 1CC, 3CC, 5CC, and 10CCInviro Medical · 2003
Descendant · cites it directly · 9 of its ownK092430 1 ML Fixed Needle, 3 ML Luer Lock, 5 ML Luer Lock, 10 ML Luer Lock…Inviro Medical Devices, Inc. · 2009
Descendant · 2 generations on · 3 of its ownK173743 Greenmedi Safety Filter SyringeSang-A Frontec Co., Ltd. · 2019
Descendant · 3 generations on · 2 of its ownK212635 SofjecHwajin Medical Co., Ltd. · 2023
Descendant · 4 generations on · 1 of its ownK241856 Sofjec (Single use Needle); Sofjec (Single use Syringe with or…Hlb Lifescience Co., Ltd. · 2024
Descendant · 5 generations on · 0 of its ownK253112 Sofjec (Single use Needle); Sofjec (Single use Syringe with or…Hlb Lifescience Co., Ltd. · 2026

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2009high 1 (2009) · low 0 (2010)2026

Most influential descendants

Showing 5 of 10 · See all

K0924301 ML Fixed Needle, 3 ML Luer Lock, 5 ML Luer Lock, 10 ML Luer Lock, 20 ML Luerl Lock…Inviro Medical Devices, Inc. · 2009 · cites it directly9descendants
K173743Greenmedi Safety Filter SyringeSang-A Frontec Co., Ltd. · 2019 · 2 generations on3descendants
K212635SofjecHwajin Medical Co., Ltd. · 2023 · 3 generations on2descendants
K241856Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec…Hlb Lifescience Co., Ltd. · 2024 · 4 generations on1descendant
K253112Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec…Hlb Lifescience Co., Ltd. · 2026 · 5 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K941450	Inviro Syringe	Dr. F. Ross Sharp, Ltd.	1994	—
0 (this device)	K032780	Inviro Snap Safety Syringe, 1CC, 3CC, 5CC, and 10CC	Inviro Medical	2003	—
+1	K092430	1 ML Fixed Needle, 3 ML Luer Lock, 5 ML Luer Lock, 10 ML Luer Lock, 20 ML…	Inviro Medical Devices, Inc.	2009	—
+2	K173743	Greenmedi Safety Filter Syringe	Sang-A Frontec Co., Ltd.	2019	—
+3	K212635	Sofjec	Hwajin Medical Co., Ltd.	2023	—
+4	K241856	Sofjec (Single use Needle); Sofjec (Single use Syringe with or without…	Hlb Lifescience Co., Ltd.	2024	—
+5	K253112	Sofjec (Single use Needle); Sofjec (Single use Syringe with or without…	Hlb Lifescience Co., Ltd.	2026	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0
2011	1	0
2012	1	0
2015	1	0
2016	1	0
2019	1	0
2021	1	0
2023	1	0
2024	1	0
2026	1	0

FIG. 1 — Lineage of K032780, 1994–2026Source: 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 MEG? 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 MEG device

#1 K192551 1ml Luer Slip or Luer Lock Syringe, Syringe…score 19.6 · 7 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? (1)

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
*	K941450	Inviro Syringe Summary page 1 …ation Name: Piston Syringe with Safety Syringe C: Predicate Device; lnviro 6 cc Syringe Predicate 51O(k) #: K941450 0. Device Description: The lnviro Snap Safety Syringe is a retractable type anti-needlestick syringe…	Dr. F. Ross Sharp, Ltd.	1994	—

Also cleared against K941450: 2 other devices →

What descends from it? (10)

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

Number	Device	Applicant	Decided	Descendants
K092430	1 ML Fixed Needle, 3 ML Luer Lock, 5 ML Luer Lock, 10 ML Luer Lock, 20 ML Luerl Lock…	Inviro Medical Devices, Inc.	2009	9
K101560	Medline Retractable Safety Syringe	Medline Industries, Inc.	2011	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 no recall.
Of its descendants, K092430 (Inviro Medical Devices, Inc., 2009) has gone furthest, with 9 descendants of its own.
2 other devices also cite its predicate K941450.

How does its category compare?

All MEG devices

MEG Syringe, Antistick: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MEG

1in 2025

2007high 13 (2022) · low 0 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MEG

229in 2023

2007high 296 (2020) · low 100 (2007)2026

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

Recalls per year · MEG

1in 2024

2007high 5 (2013) · low 0 (2007)2026

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

Adverse event reports per year · MEG

148in 2025

2007high 541 (2021) · low 20 (2008)2025

MAUDE reports naming product code MEG, 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	8	100	0	21
2008	4	145	1	20
2009	2	—	0	26
2010	2	—	1	34
2011	5	113	0	34
2012	5	109	0	22
2013	1	—	5	27
2014	5	153	0	36
2015	7	253	1	51
2016	3	179	0	94
2017	3	130	0	181
2018	1	—	0	269
2019	4	249	0	497
2020	4	296	0	353
2021	5	152	0	541
2022	13	216	0	170
2023	5	229	0	120
2024	0	—	1 (1)	112
2025	1	—	0	148
2026	1	—	0	—

What is it indicated for?

The Inviro Snap Safety Syringe is used to inject fluids into, or withdraw fluids from, the body. In addition, the Inviro Snap Safety Syringe is designed to aid in the prevention of needle stick injuries.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K032780 · printed Nov 5, 2026

Cite this page

510(k) Report. “K032780: Inviro Snap Safety Syringe, 1CC, 3CC, 5CC, and 10CC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K032780

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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