510(k) · Cleared

Cleared

Stryker Discmonitor

K050753510(k) TraditionalCleared May 18, 200556-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

Stryker Instruments · FMF Syringe, Piston

Cleared on May 18, 2005 as substantially equivalent to K011811 (Merit Medical Systems, Inc., 2001) and 4 other predicates after a 56-day review. Its family tree reaches back 4 generations to 1996.

Decided: May 18, 2005
Review: 56 days
Class: Class II
Product code: FMF
Recalls: None
Predicates: 5

Its longest line of descent runs back 4 generations to K953522 (1996). 14 ancestors in all, the oldest K884913 (1989). No later device cites it as a predicate yet.

By dateBy generation

Root · 4 generations backK953522 Usci Ideal Ptca KitRyder Intl. Corp. · 1996
3 generations backK962611 Bard Eagle Inflation DeviceRyder Intl. Corp. · 1996
2 generations backK972964 Atrion Medical Balloon Catheter Inflation DeviceAtrion Medical Products, Inc. · 1997
1 generation backK020333 Atrion Medical QL Fluid Dispensing SyringeAtrion Medical Products, Inc. · 2002
This deviceK050753 Stryker DiscmonitorStryker Instruments · 2005

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K953522	Usci Ideal Ptca Kit	Ryder Intl. Corp.	1996	—
−3	K962611	Bard Eagle Inflation Device	Ryder Intl. Corp.	1996	—
−2	K972964	Atrion Medical Balloon Catheter Inflation Device	Atrion Medical Products, Inc.	1997	—
−1	K020333	Atrion Medical QL Fluid Dispensing Syringe	Atrion Medical Products, Inc.	2002	—
0 (this device)	K050753	Stryker Discmonitor	Stryker Instruments	2005	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1989	1	0
1991	2	0
1992	1	0
1995	1	0
1996	1	0
1997	1	0
1999	1	0
2001	1	0
2004	1	0

FIG. 1 — Lineage of K050753, 1996–2005Source: 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 FMF? 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

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What was it cleared against? (5)

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
*	K011811	Monarch Inflation Syringe; Universal Fluid Dispensing Syringe Summary page 1 …: Injector and Syringe, Angiographic 21 CFR§ 870.1650, DXT Predicate Devices: Merit Medical 3OATM Monarch - K01 1811 Merit Medical Universal Fluid Dispensing Syringe - K973230 Merit Medi…	Merit Medical Systems, Inc.	2001	10
*	K973230	Monarch (in 2125)/Intellisystem (in 1125) Summary page 1 …CFR§ 870.1650, DXT Predicate Devices: Merit Medical 3OATM Monarch - K01 1811 Merit Medical Universal Fluid Dispensing Syringe - K973230 Merit Medical Intellisystemn 11Color Monitor - K993341 Physician Indu…	Merit Medical Systems, Inc.	1997	3
*	K993341	Intellisystem II Color Monitor Summary page 1 …811 Merit Medical Universal Fluid Dispensing Syringe - K973230 Merit Medical Intellisystemn 11Color Monitor - K993341 Physician Industries Accumeter - K033739 Atrion Medical QL~h Fluid Di…	Merit Medical Systems, Inc.	1999	4
*	K033739	Physician Industries' Durameter Syringe Summary page 1 …ing Syringe - K973230 Merit Medical Intellisystemn 11Color Monitor - K993341 Physician Industries Accumeter - K033739 Atrion Medical QL~h Fluid Dispensing Syringe - K020333 Description: The Stryker Disomonitor is a s…	Physician Industries, Inc.	2004	—
*	K020333	Atrion Medical QL Fluid Dispensing Syringe Summary page 1 …lor Monitor - K993341 Physician Industries Accumeter - K033739 Atrion Medical QL~h Fluid Dispensing Syringe - K020333 Description: The Stryker Disomonitor is a sterile, disposable device used to inject fluid into the intervertebral disc nucleus d…	Atrion Medical Products, Inc.	2002	—

Also cleared against K011811: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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?

The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 3.1 years on median.
4 of the 14 ancestors have a recall of any class.
2 other devices also cite its predicate K011811.

How does its category compare?

All FMF devices

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

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 Stryker Discmonitor is used to inject fluids into the intervertebral disc nucleus during discography procedures and monitor the pressure of that fluid.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K050753 · printed Nov 3, 2026

Cite this page

510(k) Report. “K050753: Stryker Discmonitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K050753

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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