510(k) · Cleared

Cleared

Genie, Model CH-200

K070633510(k) TraditionalCleared Jun 5, 200790-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 Jun 5, 2007 as substantially equivalent to K001368 (Carmel Pharma Ab., 2000) after a 90-day review. Its family tree reaches back 1 generation to 2000. 2 of the 15 devices in its family, counting itself, have a Class I recall. 13 later devices descend from it.

Decided: Jun 5, 2007
Review: 90 days
Class: Class II
Product code: FMF
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K001368 (2000). 13 later devices descend from it, 1 citing it directly. 2 of the 15 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 1 generation backK001368 Protector 21, Protector 50, Protector 14, Injector Luer Lock…Carmel Pharma Ab. · 2000 · Recalled
This deviceK070633 Genie, Model CH-200Icu Medical, Inc. · 2007
Descendant · cites it directly · 12 of its ownK081361 Chemoclave Cytotoxic Medication Preparation and Delivery System…Icu Medical, Inc. · 2008 · Recalled (Class I)
Descendant · 2 generations on · 10 of its ownK131549 Chemolock, Chemolock PortIcu Medical, Inc. · 2013 · Recalled (Class I)
Descendant · 3 generations on · 9 of its ownK141448 Tevadaptor Closed Drug Reconstitution and Transfer SystemTeva Medical Ltd., Migada Plant · 2015
Descendant · 4 generations on · 3 of its ownK192866 Chemfort CSTDSimplivia Healthcare, Ltd. · 2020 · Recalled
Descendant · 4 generations on · 1 of its ownK201422 Arisure Closed System Drug Transfer Device (CSTD)Yukon Medical, LLC · 2021

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2008high 2 (2018) · low 0 (2009)2026

Class I recalls in this family

K081361 Chemoclave Cytotoxic Medication Preparation and…cites it directly · 2008
K131549 Chemolock, Chemolock Port2 generations on · 2013

Most influential descendants

Showing 5 of 13 · See all

K081361Chemoclave Cytotoxic Medication Preparation and Delivery System, Model, CH-XXXXIcu Medical, Inc. · 2008 · cites it directly12descendants
K131549Chemolock, Chemolock PortIcu Medical, Inc. · 2013 · 2 generations on10descendants
K141448Tevadaptor Closed Drug Reconstitution and Transfer SystemTeva Medical Ltd., Migada Plant · 2015 · 3 generations on9descendants
K192866Chemfort CSTDSimplivia Healthcare, Ltd. · 2020 · 4 generations on3descendants
K201422Arisure Closed System Drug Transfer Device (CSTD)Yukon Medical, LLC · 2021 · 4 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K001368	Protector 21, Protector 50, Protector 14, Injector Luer Lock, Infusion Adapter	Carmel Pharma Ab.	2000	4
0 (this device)	K070633	Genie, Model CH-200	Icu Medical, Inc.	2007	—
+1	K081361	Chemoclave Cytotoxic Medication Preparation and Delivery System, Model, CH-XXXX	Icu Medical, Inc.	2008	Class I
+2	K131549	Chemolock, Chemolock Port	Icu Medical, Inc.	2013	Class I
+3	K141448	Tevadaptor Closed Drug Reconstitution and Transfer System	Teva Medical Ltd., Migada Plant	2015	—
+4	K192866	Chemfort CSTD	Simplivia Healthcare, Ltd.	2020	1
+4	K201422	Arisure Closed System Drug Transfer Device (CSTD)	Yukon Medical, LLC	2021	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	1
2013	1	1
2015	1	0
2017	1	0
2018	2	0
2020	1	0
2021	2	0
2023	1	0
2024	1	0
2025	2	0

FIG. 1 — Lineage of K070633, 2000–2025Source: 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.

2 devices in this family have a Class I recall. 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 FMF device

#1 K241821 Luer Lock Syringe with Safety Needle; Luer…score 16.2 · 8 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

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
*	K001368	Protector 21, Protector 50, Protector 14, Injector Luer Lock, Infusion Adapter	Carmel Pharma Ab.	2000	4

Also cleared against K001368: 4 other devices →

What descends from it? (13)

See all 13

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K081361	Chemoclave Cytotoxic Medication Preparation and Delivery System, Model, CH-XXXX Class I	Icu Medical, Inc.	2008	12

Has anything in its family been recalled? (2 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K081361Chemoclave Cytotoxic Medication Preparation and Delivery System, Model, CH-XXXXIcu Medical, Inc. · 2008 · Cites it directly · ◆ in the 2008 descendants bar of FIG. 12 Class I recalls
K131549Chemolock, Chemolock PortIcu Medical, Inc. · 2013 · 2 generations on · ◆ in the 2013 descendants bar of FIG. 12 Class I recalls

What does this lineage say?

Its one ancestor has a recall.
Of its descendants, K081361 (Icu Medical, Inc., 2008) has gone furthest, with 12 descendants of its own.
4 other devices also cite its predicate K001368.

How does its category compare?

All FMF devices

FMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · FMF

13in 2025

2007high 24 (2022) · low 8 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FMF

114in 2025

2007high 239 (2026) · low 74 (2008)2026

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

Recalls per year · FMF

19in 2023

2007high 19 (2023) · low 0 (2016)2026

Class I (19 since 2007) Class II/III not classified

Adverse event reports per year · FMF

4,181in 2025

2007high 5,874 (2021) · low 186 (2011)2025

MAUDE reports naming product code FMF, 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	23	90	6	674
2008	9	74	11	691
2009	14	94	15	913
2010	11	130	12	679
2011	16	109	3	186
2012	9	86	6	307
2013	12	154	1	326
2014	13	84	1	244
2015	11	87	2	273
2016	12	146	0	684
2017	13	135	3	1,858
2018	8	87	2	3,952
2019	11	146	1	5,863
2020	15	107	2	5,334
2021	20	175	1	5,874
2022	24	211	2	5,233
2023	22	173	19 (18)	5,214
2024	14	130	0	5,122
2025	13	114	0	4,181
2026	9	239	2 (1)	—

What is it indicated for?

The Genie is an accessory to a syringe that provides a mean of sterile access to drug vials without the use of conventional needles (needleless). These devices are designed to improve user safety by reducing the exposure that health-care workers are subjected to regarding aerosolizing hazards and accidental needle sticks.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K070633 · printed Nov 4, 2026

Cite this page

510(k) Report. “K070633: Genie, Model CH-200.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K070633

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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