510(k) · Cleared
ClearedPlastic LOR Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jiangsu Caina Medical Co.,Ltd · CAZ Anesthesia Conduction Kit
Cleared on Feb 12, 2021 as substantially equivalent to K061737 (Robert Busse & Co., Inc., 2006) and 1 other predicate after a 267-day review. Its family tree reaches back 3 generations to 1993.
- Decided
- Feb 12, 2021
- Review
- 267 days
- Class
- Class II
- Product code
- CAZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K925902 (1993). No later device cites it as a predicate yet.
- Root · 3 generations backK925902 B-D Loss of Resistance SyringeBd Becton Dickinson Vacutainer Systems Preanalytic · 1993
- 2 generations backK061737 Loss of Resistance SyringeRobert Busse & Co., Inc. · 2006
- 1 generation backK190345 VPCPAJUNK GmbH Medizintechnologie · 2019
- This deviceK201356 Plastic LOR SyringeJiangsu Caina Medical Co.,Ltd · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K925902 | B-D Loss of Resistance Syringe | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1993 | — |
| −2 | K061737 | Loss of Resistance Syringe | Robert Busse & Co., Inc. | 2006 | — |
| −1 | K190345 | VPC | PAJUNK GmbH Medizintechnologie | 2019 | — |
| 0 (this device) | K201356 | Plastic LOR Syringe | Jiangsu Caina Medical Co.,Ltd | 2021 | — |
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 CAZ? 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 CAZ device
- #1 K261372 Profoject™ LOR Syringescore 12.4 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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 | Decided |
|---|---|---|---|
| * | K061737 | Loss of Resistance SyringeSummary page 5…ring the shelf life of five years. The intended patient population is adults. 5. Identification of Predicate Device Predicate device 1 510(k) Number: K061737 2 / 9… | 2006 |
| * | K190345 | VPCSummary page 6…K201356 Page 3 of 9 Product Name: Busse Loss of Resistance Syringe Predicate device 2 510(k) Number: K190345 Product Name: VPC 6. Non-Clinical Test Conclusion Non clinical tests were conducted to verify that the proposed de… | 2019 |
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 28 years and passes through 4 companies; a new generation was cleared every 12.4 years on median.
- None of the 3 ancestors has a recall.
- 3 other devices also cite its predicate K061737.
How does its category compare?
All CAZ devicesCAZ Anesthesia Conduction Kit: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · CAZ
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · CAZ
108in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CAZ
1in 2024
Class I (11 since 2007) Class II/III not classified
Adverse event reports per year · CAZ
137in 2025
MAUDE reports naming product code CAZ, 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 | 4 | 172 | 0 | 81 |
| 2008 | 4 | 99 | 0 | 80 |
| 2009 | 2 | — | 29 | 134 |
| 2010 | 2 | — | 8 | 139 |
| 2011 | 1 | — | 2 | 187 |
| 2012 | 9 | 108 | 0 | 187 |
| 2013 | 0 | — | 12 | 276 |
| 2014 | 0 | — | 2 | 251 |
| 2015 | 1 | — | 1 | 235 |
| 2016 | 2 | — | 1 | 372 |
| 2017 | 0 | — | 0 | 353 |
| 2018 | 0 | — | 0 | 448 |
| 2019 | 1 | — | 0 | 472 |
| 2020 | 1 | — | 0 | 274 |
| 2021 | 1 | — | 0 | 165 |
| 2022 | 1 | — | 0 | 270 |
| 2023 | 1 | — | 0 | 60 |
| 2024 | 0 | — | 1 | 165 |
| 2025 | 0 | — | 0 | 137 |
| 2026 | 1 | — | 12 (11) | — |
What is it indicated for?
The Plastic LOR Syringe is intended for use in conjunction with an epidural needle, to verify the needle tip placement in the epidural space by the loss of Resistance technique, it will be filled with air and/or saline during use. The loss of Resistance Syringe is not intended for injection or aspiration. The syringe will be sold sterile individually packaged, and as part of a sterile kit.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K201356 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201356: Plastic LOR Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201356
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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