510(k) · Cleared

Cleared

Rmi Dual Fluid Irrigating Syringe

K964833510(k) TraditionalCleared Feb 19, 199779-day reviewClass I21 CFR 880.6960

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

Research Medical, Inc. · KYZ Syringe, Irrigating (Non Dental)

Cleared on Feb 19, 1997 as substantially equivalent to K881020 (Micromedics, Inc., 1988) and 1 other predicate after a 79-day review. Its family tree reaches back 1 generation to 1987. 8 later devices descend from it.

Decided: Feb 19, 1997
Review: 79 days
Class: Class I
Product code: KYZ
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K872565 (1987). 2 ancestors in all. 8 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK872565 Duoflo DispenserHemaedics, Inc. · 1987
This deviceK964833 Rmi Dual Fluid Irrigating SyringeResearch Medical, Inc. · 1997
Descendant · cites it directly · 7 of its ownK973510 Duploject (0.5/1.0 ML, 2.0 ML, 5.0 ML)Immuno-U.S., Inc. · 1997
Descendant · 2 generations on · 3 of its ownK981089 Tissomat and Spray SetBaxter Healthcare Corp · 2000
Descendant · 2 generations on · 1 of its ownK020666 Duploject Easy-Prep System 1ML, 2ML, 5MLBaxter Healthcare Corp · 2002 · Recalled
Descendant · 3 generations on · 0 of its ownK071126 Cryoseal FS Applicator SystemThermogenesis Corp. · 2007
Descendant · 2 generations on · 0 of its ownK063535 Caption ApplicatorSmith & Nephew, Inc. · 2007

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

1997high 2 (2007) · low 0 (1998)2026

Most influential descendants

Showing 5 of 8 · See all

K973510Duploject (0.5/1.0 ML, 2.0 ML, 5.0 ML)Immuno-U.S., Inc. · 1997 · cites it directly7descendants
K981089Tissomat and Spray SetBaxter Healthcare Corp · 2000 · 2 generations on3descendants
K020666Duploject Easy-Prep System 1ML, 2ML, 5MLBaxter Healthcare Corp · 2002 · 2 generations on1descendant
K071126Cryoseal FS Applicator SystemThermogenesis Corp. · 2007 · 3 generations on0descendants
K063535Caption ApplicatorSmith & Nephew, Inc. · 2007 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K872565	Duoflo Dispenser	Hemaedics, Inc.	1987	—
0 (this device)	K964833	Rmi Dual Fluid Irrigating Syringe	Research Medical, Inc.	1997	—
+1	K973510	Duploject (0.5/1.0 ML, 2.0 ML, 5.0 ML)	Immuno-U.S., Inc.	1997	—
+2	K981089	Tissomat and Spray Set	Baxter Healthcare Corp	2000	—
+2	K020666	Duploject Easy-Prep System 1ML, 2ML, 5ML	Baxter Healthcare Corp	2002	1
+3	K071126	Cryoseal FS Applicator System	Thermogenesis Corp.	2007	—
+2	K063535	Caption Applicator	Smith & Nephew, Inc.	2007	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1988	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
2000	1	0
2002	1	0
2003	1	0
2004	1	0
2005	1	0
2007	2	0

FIG. 1 — Lineage of K964833, 1987–2007Source: 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 KYZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

Get a 510(k) 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	Applicant	Decided	Recalls
*	K881020	Surgical Sealant Dispenser (SSD) Summary page 1 …al equivalence of the RMI Dual Fluid Irrigating Syringe 1s made to the following predicate devices: . Micromedics, Inc. Surgical Sealant Dispenser (SSD); S10(k) Number K881020. [Also marketed as the Micromedics Fibrijet Delivery System] Marketed by : Micromedics, Inc. 1285 Corporate Center Drive #150 Eag…	Micromedics, Inc.	1988	1
*	K872565	Duoflo Dispenser Summary page 2 …by : Micromedics, Inc. 1285 Corporate Center Drive #150 Eagan, Minnesota 55121 Phone: (612) 452-1977 Fax: (612) 452-1787 Duollo™ Dispenser; S10(k) Number K872565. Marketed by © Hemacedics, Inc. 2649 Scahorn Drive Malibu, CA 90265 Phone: (213) 454-4757 Summary of Biocompatibility: A Prima…	Hemaedics, Inc.	1987	—

Also cleared against K881020: 2 other devices →

What descends from it? (8)

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

Number	Device	Applicant	Decided	Descendants
K973510	Duploject (0.5/1.0 ML, 2.0 ML, 5.0 ML)	Immuno-U.S., Inc.	1997	7

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?

1 of the 2 ancestors has a recall of any class.
Of its descendants, K973510 (Immuno-U.S., Inc., 1997) has gone furthest, with 7 descendants of its own.
2 other devices also cite its predicate K881020.

How does its category compare?

All KYZ devices

KYZ Syringe, Irrigating (Non Dental): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KYZ

1in 2020

2007high 1 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KYZ

Too few KYZ 510(k)s in any year since 2007 to give a median.

Recalls per year · KYZ

1in 2023

2007high 5 (2016) · low 0 (2007)2026

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

Adverse event reports per year · KYZ

28in 2025

2007high 106 (2024) · low 0 (2007)2025

MAUDE reports naming product code KYZ, 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	0	—	0	0
2008	0	—	0	4
2009	1	—	1	3
2010	0	—	2	2
2011	1	—	1	4
2012	0	—	0	1
2013	0	—	0	12
2014	0	—	0	10
2015	0	—	0	11
2016	0	—	5	8
2017	0	—	0	52
2018	0	—	1	76
2019	0	—	0	69
2020	1	—	0	88
2021	0	—	0	41
2022	0	—	0	11
2023	0	—	1 (1)	14
2024	0	—	0	106
2025	0	—	0	28
2026	0	—	1	—

https://510kreport.com/device/K964833 · printed Nov 6, 2026

Cite this page

510(k) Report. “K964833: Rmi Dual Fluid Irrigating Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964833

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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