510(k) · Cleared

Cleared

Pre-Filled 10CC Inflation Syringe W/Sterile Water

K943836510(k) TraditionalCleared Nov 21, 1994108-day reviewClass II21 CFR 880.6740

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

Orion Life Systems, Inc. · JOL Catheter And Tip, Suction

Cleared on Nov 21, 1994 after a 108-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 of the 5 devices in its family, counting itself, has a Class I recall. 4 later devices descend from it.

Decided: Nov 21, 1994
Review: 108 days
Class: Class II
Product code: JOL
Recalls: None
Predicates: 0

4 later devices descend from it, 1 citing it directly. 1 of the 5 devices in this family, counting this one, has a Class I recall.

This deviceK943836 Pre-Filled 10CC Inflation Syringe W/Sterile WaterOrion Life Systems, Inc. · 1994
Descendant · cites it directly · 3 of its ownK030813 Primary Care Solutions Prefilled 10CC and Prefilled 30CC Inflation…Primary Care Solutions, Inc. · 2003 · Recalled (Class I)
Descendant · 2 generations on · 1 of its ownK181814 AMSure Pre-filled Syringe for Balloon Inflation with Sterile WaterAmsino International, Inc. · 2018
Descendant · 2 generations on · 0 of its ownK202698 Prefilled SyringeHangzhou Primecare Medical Co., Ltd. · 2020
Descendant · 3 generations on · 0 of its ownK200556 AquaFlate Pre-Filled Sterile Water Syringe 10mLH R Pharmaceuticals, Inc. · 2020

Class I recalls in this family

K030813 Primary Care Solutions Prefilled 10CC and…cites it directly · 2003

Most influential descendants

Showing 4 of 4 · See all

K030813Primary Care Solutions Prefilled 10CC and Prefilled 30CC Inflation Syringes with Sterile…Primary Care Solutions, Inc. · 2003 · cites it directly3descendants
K181814AMSure Pre-filled Syringe for Balloon Inflation with Sterile WaterAmsino International, Inc. · 2018 · 2 generations on1descendant
K202698Prefilled SyringeHangzhou Primecare Medical Co., Ltd. · 2020 · 2 generations on0descendants
K200556AquaFlate Pre-Filled Sterile Water Syringe 10mLH R Pharmaceuticals, Inc. · 2020 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K943836	Pre-Filled 10CC Inflation Syringe W/Sterile Water	Orion Life Systems, Inc.	1994	—
+1	K030813	Primary Care Solutions Prefilled 10CC and Prefilled 30CC Inflation Syringes…	Primary Care Solutions, Inc.	2003	Class I
+2	K181814	AMSure Pre-filled Syringe for Balloon Inflation with Sterile Water	Amsino International, Inc.	2018	—
+2	K202698	Prefilled Syringe	Hangzhou Primecare Medical Co., Ltd.	2020	—
+3	K200556	AquaFlate Pre-Filled Sterile Water Syringe 10mL	H R Pharmaceuticals, Inc.	2020	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	1
2018	1	0
2020	2	0

FIG. 1 — Lineage of K943836, 1994–2020Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

1 device in this family has a Class I recall. 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (4)

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

Number	Device	Applicant	Decided	Descendants
K030813	Primary Care Solutions Prefilled 10CC and Prefilled 30CC Inflation Syringes with Sterile… Class I	Primary Care Solutions, Inc.	2003	3

Has anything in its family been recalled? (1 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.

K030813Primary Care Solutions Prefilled 10CC and Prefilled 30CC Inflation Syringes with Sterile Water Catalog…Primary Care Solutions, Inc. · 2003 · Cites it directly · ◆ in the 2003 descendants bar of FIG. 12 Class I recalls

What does this lineage say?

Of its descendants, K030813 (Primary Care Solutions, Inc., 2003) has gone furthest, with 3 descendants of its own.

How does its category compare?

All JOL devices

JOL Catheter And Tip, Suction: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JOL

FDA has decided no JOL device since 2007.

Median 510(k) review, days · JOL

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

Recalls per year · JOL

1in 2023

2007high 3 (2019) · low 0 (2007)2026

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

Adverse event reports per year · JOL

277in 2025

2007high 442 (2019) · low 14 (2008)2025

MAUDE reports naming product code JOL, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	17
2008	—	0	14
2009	—	0	17
2010	—	0	25
2011	—	0	17
2012	—	1	25
2013	—	0	34
2014	—	0	42
2015	—	0	27
2016	—	0	61
2017	—	0	181
2018	—	0	161
2019	—	3	442
2020	—	0	187
2021	—	0	283
2022	—	0	221
2023	—	1 (1)	197
2024	—	0	277
2025	—	0	277
2026	—	1	—

https://510kreport.com/device/K943836 · printed Nov 6, 2026

Cite this page

510(k) Report. “K943836: Pre-Filled 10CC Inflation Syringe W/Sterile Water.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K943836

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026