510(k) · Cleared
Recalled · Class I · 2023Primary Care Solutions Prefilled 10CC and Prefilled 30CC Inflation Syringes with Sterile Water Catalog Numbers 1010 and
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Primary Care Solutions, Inc. · EZL Catheter, Retention Type, Balloon
Cleared on May 30, 2003 as substantially equivalent to K943836 (Orion Life Systems, Inc., 1994) after a 77-day review. Its family tree reaches back 1 generation to 1994. 1 of the 5 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it. It has been recalled 27 times, including 2 Class I recalls.
- Decided
- May 30, 2003
- Review
- 77 days
- Class
- Class II
- Product code
- EZL
- Recalls
- 27 (2 Class I)
- Predicates
- 1
Its longest line of descent runs back 1 generation to K943836 (1994). 3 later devices descend from it, 2 citing it directly. 1 of the 5 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK943836 Pre-Filled 10CC Inflation Syringe W/Sterile WaterOrion Life Systems, Inc. · 1994
- This deviceK030813 Primary Care Solutions Prefilled 10CC and Prefilled 30CC Inflation…Primary Care Solutions, Inc. · 2003
- Descendant · cites it directly · 1 of its ownK181814 AMSure Pre-filled Syringe for Balloon Inflation with Sterile WaterAmsino International, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK202698 Prefilled SyringeHangzhou Primecare Medical Co., Ltd. · 2020
- Descendant · 2 generations on · 0 of its ownK200556 AquaFlate Pre-Filled Sterile Water Syringe 10mLH R Pharmaceuticals, Inc. · 2020
Most influential descendants
Showing 3 of 3 · See all- K181814AMSure Pre-filled Syringe for Balloon Inflation with Sterile WaterAmsino International, Inc. · 2018 · cites it directly1descendant
- K202698Prefilled SyringeHangzhou Primecare Medical Co., Ltd. · 2020 · cites it directly0descendants
- K200556AquaFlate Pre-Filled Sterile Water Syringe 10mLH R Pharmaceuticals, Inc. · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K943836 | Pre-Filled 10CC Inflation Syringe W/Sterile Water | Orion Life Systems, Inc. | 1994 | — |
| 0 (this device) | K030813 | Primary Care Solutions Prefilled 10CC and Prefilled 30CC Inflation Syringes… | Primary Care Solutions, Inc. | 2003 | — |
| +1 | K181814 | AMSure Pre-filled Syringe for Balloon Inflation with Sterile Water | Amsino International, Inc. | 2018 | — |
| +1 | K202698 | Prefilled Syringe | Hangzhou Primecare Medical Co., Ltd. | 2020 | — |
| +2 | 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 |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
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.
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.
Top candidate predicates for a new EZL device
- #1 K260756 TraumaGuard Intra-Abdominal Pressure-Sensing…score 13.2 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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 | Decided |
|---|---|---|---|
| * | K943836 | Pre-Filled 10CC Inflation Syringe W/Sterile WaterSummary page 1…Inflation Class: I1 Reason for Application: New Devices to Primary C u e Solutions, Inc Predicate Dcvices. K943836 - Pre-Fillcd lOcc Inflation Syringe with Sterile Water… | 1994 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 6, 2023 | Class I | Z-0515-2024 | Process control | Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside kits, have the potential for a lack of sterility assurance, which could result in a nonsterile product, use of which could cause infection. |
| Nov 6, 2023 | Class I | Z-0511-2024 | Process control | Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside kits, have the potential for a lack of sterility assurance, which could result in a nonsterile product, use of which could cause infection. |
| Jan 22, 2016 | Class II | Z-1212-2016 | Nonconforming Material/Component | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria |
| Jan 22, 2016 | Class II | Z-1223-2016 | Nonconforming Material/Component | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria |
| Jan 22, 2016 | Class II | Z-1209-2016 | Nonconforming Material/Component | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria |
| Jan 22, 2016 | Class II | Z-1224-2016 | Nonconforming Material/Component | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria |
| Jan 22, 2016 | Class II | Z-1219-2016 | Nonconforming Material/Component | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria |
| Jan 22, 2016 | Class II | Z-1227-2016 | Nonconforming Material/Component | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria |
| Jan 22, 2016 | Class II | Z-1218-2016 | Nonconforming Material/Component | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria |
| Jan 22, 2016 | Class II | Z-1221-2016 | Nonconforming Material/Component | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria |
| Jan 22, 2016 | Class II | Z-1210-2016 | Nonconforming Material/Component | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria |
| Jan 22, 2016 | Class II | Z-1226-2016 | Nonconforming Material/Component | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria |
| Jan 22, 2016 | Class II | Z-1229-2016 | Nonconforming Material/Component | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria |
| Jan 22, 2016 | Class II | Z-1220-2016 | Nonconforming Material/Component | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria |
| Jan 22, 2016 | Class II | Z-1228-2016 | Nonconforming Material/Component | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria |
| Jan 22, 2016 | Class II | Z-1211-2016 | Nonconforming Material/Component | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria |
| Jan 22, 2016 | Class II | Z-1215-2016 | Nonconforming Material/Component | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria |
| Jan 22, 2016 | Class II | Z-1222-2016 | Nonconforming Material/Component | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria |
| Jan 22, 2016 | Class II | Z-1203-2016 | Nonconforming Material/Component | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria |
| Jan 22, 2016 | Class II | Z-1214-2016 | Nonconforming Material/Component | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria |
| Jan 22, 2016 | Class II | Z-1206-2016 | Nonconforming Material/Component | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria |
| Jan 22, 2016 | Class II | Z-1208-2016 | Nonconforming Material/Component | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria |
| Jan 22, 2016 | Class II | Z-1213-2016 | Nonconforming Material/Component | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria |
| Jan 22, 2016 | Class II | Z-1205-2016 | Nonconforming Material/Component | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria |
| Jan 22, 2016 | Class II | Z-1225-2016 | Nonconforming Material/Component | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria |
| Jan 22, 2016 | Class II | Z-1216-2016 | Nonconforming Material/Component | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria |
| Jan 22, 2016 | Class II | Z-1217-2016 | Nonconforming Material/Component | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria |
The 5 latest of 27 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K181814 (Amsino International, Inc., 2018) has gone furthest, with 1 descendant of its own.
How does its category compare?
All EZL devicesEZL Catheter, Retention Type, Balloon: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EZL
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EZL
123in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EZL
2in 2024
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · EZL
1,381in 2025
MAUDE reports naming product code EZL, 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 | 7 | 186 | 0 | 8 |
| 2008 | 2 | — | 0 | 6 |
| 2009 | 4 | 114 | 0 | 6 |
| 2010 | 1 | — | 0 | 27 |
| 2011 | 2 | — | 0 | 79 |
| 2012 | 0 | — | 0 | 65 |
| 2013 | 3 | 151 | 0 | 99 |
| 2014 | 2 | — | 0 | 229 |
| 2015 | 3 | 132 | 0 | 303 |
| 2016 | 1 | — | 0 | 326 |
| 2017 | 2 | — | 0 | 571 |
| 2018 | 9 | 177 | 0 | 677 |
| 2019 | 3 | 266 | 1 | 671 |
| 2020 | 4 | 137 | 0 | 712 |
| 2021 | 2 | — | 0 | 702 |
| 2022 | 2 | — | 0 | 884 |
| 2023 | 3 | 282 | 2 (2) | 772 |
| 2024 | 5 | 123 | 2 | 1,029 |
| 2025 | 1 | — | 0 | 1,381 |
| 2026 | 4 | 170 | 2 | — |
What is it indicated for?
A sterile water pre-filled syringe for use in inflating foley catheter balloon
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030813 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030813: Primary Care Solutions Prefilled 10CC and Prefilled 30CC Inflation Syringes with Sterile Water Catalog Numbers 1010 and.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030813
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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