510(k) · Cleared
ClearedLoss of Resistance Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Robert Busse & Co., Inc. · CAZ Anesthesia Conduction Kit
Cleared on Dec 18, 2006 as substantially equivalent to K925902 (Bd Becton Dickinson Vacutainer Systems Preanalytic, 1993) after a 181-day review. Its family tree reaches back 1 generation to 1993. 4 later devices descend from it.
- Decided
- Dec 18, 2006
- Review
- 181 days
- Class
- Class II
- Product code
- CAZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K925902 (1993). 4 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK925902 B-D Loss of Resistance SyringeBd Becton Dickinson Vacutainer Systems Preanalytic · 1993
- This deviceK061737 Loss of Resistance SyringeRobert Busse & Co., Inc. · 2006
- Descendant · cites it directly · 1 of its ownK190345 VPCPAJUNK GmbH Medizintechnologie · 2019
- Descendant · cites it directly · 0 of its ownK261372 Profoject™ LOR SyringeCMT Health PTE., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK201356 Plastic LOR SyringeJiangsu Caina Medical Co.,Ltd · 2021
- Descendant · cites it directly · 0 of its ownK080804 Busse Plastic Lor SyringeBusse Hosipital Disposables · 2008
Most influential descendants
Showing 4 of 4 · See all- K190345VPCPAJUNK GmbH Medizintechnologie · 2019 · cites it directly1descendant
- K261372Profoject™ LOR SyringeCMT Health PTE., Ltd. · 2026 · cites it directly0descendants
- K201356Plastic LOR SyringeJiangsu Caina Medical Co.,Ltd · 2021 · cites it directly0descendants
- K080804Busse Plastic Lor SyringeBusse Hosipital Disposables · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K925902 | B-D Loss of Resistance Syringe | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1993 | — |
| 0 (this device) | K061737 | Loss of Resistance Syringe | Robert Busse & Co., Inc. | 2006 | — |
| +1 | K190345 | VPC | PAJUNK GmbH Medizintechnologie | 2019 | — |
| +1 | K261372 | Profoject™ LOR Syringe | CMT Health PTE., Ltd. | 2026 | — |
| +1 | K201356 | Plastic LOR Syringe | Jiangsu Caina Medical Co.,Ltd | 2021 | — |
| +1 | K080804 | Busse Plastic Lor Syringe | Busse Hosipital Disposables | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2026 | 1 | 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.
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? (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 |
|---|---|---|---|
| * | K925902 | B-D Loss of Resistance SyringeSummary page 1…tic Classification: Class 11, 21 CFR 868.5140 Product Code: CAZ Predicate Device: B-D Loss of Resistance Syringe - (K925902) Device Description: The Busse Loss of Resistance Syringe is a single use device,… | 1993 |
What descends from it? (4)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All CAZ devicesCAZ Anesthesia Conduction Kit: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Busse Loss of Resistance 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 as stated in the FDA summary.
https://510kreport.com/device/K061737 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061737: Loss of Resistance Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061737
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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