510(k) · Cleared
ClearedAtrion Epidural Anesthesia Kit with Atrion Needlevise Sharps Securing System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Atrion Medical Products, Inc. · CAZ Anesthesia Conduction Kit
Cleared on Jun 16, 2004 as substantially equivalent to K010038 (Cambridge Marketing, Inc., 2001) and 3 other predicates after a 44-day review. Its family tree reaches back 2 generations to 1980. 1 of the 7 devices in its family, counting itself, has a Class I recall.
- Decided
- Jun 16, 2004
- Review
- 44 days
- Class
- Class II
- Product code
- CAZ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K801912 (1980). 6 ancestors in all, the oldest K802065 (1980). No later device cites it as a predicate yet. 1 of the 7 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK801912 Arrow Positive Placement Con/Epidural anArrow Intl., Inc. · 1980 · Recalled (Class I)
- 1 generation backK971233 Soft Tip Epidural Catheter KitB.Braun Medical, Inc. · 1997
- This deviceK041158 Atrion Epidural Anesthesia Kit with Atrion Needlevise Sharps…Atrion Medical Products, Inc. · 2004
Class I recalls in this family
- K801912 Arrow Positive Placement Con/Epidural an2 generations back · 1980
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K801912 | Arrow Positive Placement Con/Epidural an | Arrow Intl., Inc. | 1980 | Class I |
| −1 | K971233 | Soft Tip Epidural Catheter Kit | B.Braun Medical, Inc. | 1997 | — |
| 0 (this device) | K041158 | Atrion Epidural Anesthesia Kit with Atrion Needlevise Sharps Securing System | Atrion Medical Products, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1981 | 1 | 0 |
| 1995 | 1 | 0 |
| 2001 | 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.
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 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? (4)
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 |
|---|---|---|---|
| * | K010038 | Needle Barn Stick Stopper with Safety Cap, in Kit with Sterile Field DrapeSummary page 1…Telephone: (256) 586-1580, Fax: (256) 586-8529 Predicate: Cambridge Marketing, Inc. Needle Barn Stik Stopper® (K010038) Devon Industries, Inc. Point-Lok® Needle Protection Device… | 2001 |
| * | K946289 | Devons Point Lok Needle Protection DeviceSummary page 1…Barn Stik Stopper® (K010038) Devon Industries, Inc. Point-Lok® Needle Protection Device (K946289) B. Braun Epidural Kit with Soft Tip Catheter (K971233)… | 1995 |
| * | K971233 | Soft Tip Epidural Catheter KitSummary page 1…nt-Lok® Needle Protection Device (K946289) B. Braun Epidural Kit with Soft Tip Catheter (K971233) Portex Continuous Epidural Anesthesia Tray (K802065) Device Description: The Atrion Epidu… | 1997 |
| * | K802065 | Continuous Epidural Anesthesia Tray/DrugSummary page 1…B. Braun Epidural Kit with Soft Tip Catheter (K971233) Portex Continuous Epidural Anesthesia Tray (K802065) Device Description: The Atrion Epidural Anesthesia Kit with NeedleVISE TM Sharps Securing System consists of components necess… | 1980 |
What descends from it?
No later submission names this one as a predicate yet.
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.
- K801912Arrow Positive Placement Con/Epidural anArrow Intl., Inc. · 1980 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 24 years and passes through 3 companies; a new generation was cleared every 17.1 years on median.
- 1 of the 6 ancestors has a recall of any class; 1 has a Class I recall.
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 Atrion Epidural Anesthesia Kit is intended for use in the administration of anesthetic agents
into the epidural space. It is recommended that the epidural catheter be removed or replace
every 72 hours.
The NeedleVISETM sharps securing system is intended for use in sterile anesthesiology
procedure trays within the sterile field as a sharps securing device for the contaminated
specialized needles that do not have integral engineered sharps safety devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041158 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041158: Atrion Epidural Anesthesia Kit with Atrion Needlevise Sharps Securing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041158
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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