510(k) · Cleared
ClearedCorrectinject Safety System, Catheter Connector, Filter, Infusion Adaptor, Syringe Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smiths Medical Asd, Inc. · CAZ Anesthesia Conduction Kit
Cleared on Sep 14, 2012 as substantially equivalent to K965017 (Smiths Industries Medical Systems, Inc., 1997) and 4 other predicates after a 616-day review. Its family tree reaches back 2 generations to 1997. 1 of the 11 devices in its family, counting itself, has a Class I recall. 5 later devices descend from it.
- Decided
- Sep 14, 2012
- Review
- 616 days
- Class
- Class II
- Product code
- CAZ
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 2 generations to K965017 (1997). 5 ancestors in all, the oldest K801343 (1980). 5 later devices descend from it, 3 citing it directly. 1 of the 11 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK965017 Regional Anesthesia TraysSmiths Industries Medical Systems, Inc. · 1997 · Recalled
- 1 generation backK092657 Epifuse Catheter Connector, Model: 4909ESmiths Medical Asd, Inc. · 2009
- This deviceK110053 Correctinject Safety System, Catheter Connector, Filter, Infusion…Smiths Medical Asd, Inc. · 2012
- Descendant · cites it directly · 1 of its ownK170900 DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe +…Intervene Group, Ltd. · 2017
- Descendant · cites it directly · 1 of its ownK162219 CADD® Infusion Disposables Portfolio with NRFit™ connectorsSmiths Medical Asd, Inc. · 2017 · Recalled (Class I)
- Descendant · 2 generations on · 0 of its ownK211649 PCEA Syringe SetBaxter Healthcare Corporation · 2021
- Descendant · 2 generations on · 0 of its ownK201031 NRFit® Caps, Male and Female Neuraxial Tip CapsInternational Medical Industries, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK172410 Portex NRFit Epidural Needles, Portex NRFit Spinal Needles, Portex…Smiths Medical Asd, Inc. · 2018 · Recalled
Class I recalls in this family
- K162219 CADD® Infusion Disposables Portfolio with NRFit™…cites it directly · 2017
Most influential descendants
Showing 5 of 5 · See all- K170900DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe + Accessories, DASH 6…Intervene Group, Ltd. · 2017 · cites it directly1descendant
- K162219CADD® Infusion Disposables Portfolio with NRFit™ connectorsSmiths Medical Asd, Inc. · 2017 · cites it directly1descendant
- K211649PCEA Syringe SetBaxter Healthcare Corporation · 2021 · 2 generations on0descendants
- K201031NRFit® Caps, Male and Female Neuraxial Tip CapsInternational Medical Industries, Inc. · 2020 · 2 generations on0descendants
- K172410Portex NRFit Epidural Needles, Portex NRFit Spinal Needles, Portex NRFit Loss of…Smiths Medical Asd, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K965017 | Regional Anesthesia Trays | Smiths Industries Medical Systems, Inc. | 1997 | 7 |
| −1 | K092657 | Epifuse Catheter Connector, Model: 4909E | Smiths Medical Asd, Inc. | 2009 | — |
| 0 (this device) | K110053 | Correctinject Safety System, Catheter Connector, Filter, Infusion Adaptor… | Smiths Medical Asd, Inc. | 2012 | — |
| +1 | K170900 | DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe +… | Intervene Group, Ltd. | 2017 | — |
| +1 | K162219 | CADD® Infusion Disposables Portfolio with NRFit™ connectors | Smiths Medical Asd, Inc. | 2017 | Class I |
| +2 | K211649 | PCEA Syringe Set | Baxter Healthcare Corporation | 2021 | — |
| +2 | K201031 | NRFit® Caps, Male and Female Neuraxial Tip Caps | International Medical Industries, Inc. | 2020 | — |
| +1 | K172410 | Portex NRFit Epidural Needles, Portex NRFit Spinal Needles, Portex NRFit Loss… | Smiths Medical Asd, Inc. | 2018 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1998 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 1 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 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? (5)
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 |
|---|---|---|---|
| * | K965017 | Regional Anesthesia TraysSummary page 1…etTm Safety System ConimonNarne: Anesthesia Conduction Kit Classification Nanfe: Anesthesia Conduction Kit, (21 CER 868.5 140, Product Code CAZ) Predicate Device(§): K(965017, Smiths Medical ASD, Inc. Portex® Regional Anesthesia-Kits. K(092657; EpiFuseTM Catheter Connector K083451, Pontex"' Epidural Fil… | 1997 |
| * | K092657 | Epifuse Catheter Connector, Model: 4909ESummary page 1…tion Nanfe: Anesthesia Conduction Kit, (21 CER 868.5 140, Product Code CAZ) Predicate Device(§): K(965017, Smiths Medical ASD, Inc. Portex® Regional Anesthesia-Kits. K(092657; EpiFuseTM Catheter Connector K083451, Pontex"' Epidural Filter,. Model 100/386/010, Various Standard and Custom Tiays K980987, B… | 2009 |
| * | K083451 | Portex Epidural Filter, Model 100/386/010, Various Standard and Custom TraysSummary page 1…, (21 CER 868.5 140, Product Code CAZ) Predicate Device(§): K(965017, Smiths Medical ASD, Inc. Portex® Regional Anesthesia-Kits. K(092657; EpiFuseTM Catheter Connector K083451, Pontex"' Epidural Filter,. Model 100/386/010, Various Standard and Custom Tiays K980987, BD LuerzLoklM Tip Syringe K801343, BD N… | 2009 |
| * | K980987 | Becton Dickinson SyringeSummary page 1…D, Inc. Portex® Regional Anesthesia-Kits. K(092657; EpiFuseTM Catheter Connector K083451, Pontex"' Epidural Filter,. Model 100/386/010, Various Standard and Custom Tiays K980987, BD LuerzLoklM Tip Syringe K801343, BD NokorM Filter Needle Device Description The CorrectnjctM Safety System specially designe… | 1998 |
| * | K801343 | B-D Filter NeedleSummary page 1…-Kits. K(092657; EpiFuseTM Catheter Connector K083451, Pontex"' Epidural Filter,. Model 100/386/010, Various Standard and Custom Tiays K980987, BD LuerzLoklM Tip Syringe K801343, BD NokorM Filter Needle Device Description The CorrectnjctM Safety System specially designed non-bier taper-aids in-preventing… | 1980 |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170900 | DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe + Accessories, DASH 6… | 2017 | 1 |
| K162219 | CADD® Infusion Disposables Portfolio with NRFit™ connectors Class I | 2017 | 1 |
| K172410 | Portex NRFit Epidural Needles, Portex NRFit Spinal Needles, Portex NRFit Loss of… | 2018 | 0 |
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.
- K162219CADD® Infusion Disposables Portfolio with NRFit™ connectorsSmiths Medical Asd, Inc. · 2017 · Cites it directly · ◆ in the 2017 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 15 years and passes through 2 companies; a new generation was cleared every 12.6 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K170900 (Intervene Group, Ltd., 2017) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K965017.
How does its category compare?
All CAZ devicesCAZ Anesthesia Conduction Kit: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 CorrectInject™ Safety System is intended for the injection of local or regional anesthetics, narcotics or other medications indicated for neuraxial injection. The system consists of components that have a unique non-Luer taper that allows connection of compatible CorrectInject™ components that, when used together as a system, help reduce the risk of mis-connection that may result in the injection of medications not intended for neuraxial use. The…
Read the full statement (199 words)
The CorrectInject™ Safety System is intended for the injection of local or regional anesthetics, narcotics or other medications indicated for neuraxial injection. The system consists of components that have a unique non-Luer taper that allows connection of compatible CorrectInject™ components that, when used together as a system, help reduce the risk of mis-connection that may result in the injection of medications not intended for neuraxial use.
The CorrectInject™ Catheter Connector is intended for use with an epidural anesthesia catheter and CorrectInject™ compatible components for the injection of local or regional anesthetics, narcotics or other medications indicated for injection into the epidural space.
The CorrectInject™ Syringe is intended for use with CorrectInject™ compatible components for the injection of medications.
The CorrectInject™ anesthesia conduction filter is a microporous filter used while administering to a patient injections of local anesthetics to minimize particulate (foreign material) contamination of the injected fluid when used with CorrectInject™ compatible components.
The CorrectInject™ filter needle is intended to draw up medication when using the CorrectInject™ Syringe.
The CorrectInject™ white transport cap is intended to fit the CorrectInject™ syringe.
The CorrectInject™ yellow cap is intended to fit the female side of the CorrectInject™ catheter connector or CorrectInject™ filter.
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/K110053 · printed Nov 4, 2026
Cite this page
510(k) Report. “K110053: Correctinject Safety System, Catheter Connector, Filter, Infusion Adaptor, Syringe Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K110053
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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