510(k) · Cleared
ClearedNRFit® Caps, Male and Female Neuraxial Tip Caps
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
International Medical Industries, Inc. · QEH Piston Syringe With Neuraxial Connector – Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact
Cleared on Dec 16, 2020 as substantially equivalent to K170900 (Intervene Group, Ltd., 2017) after a 240-day review. Its family tree reaches back 4 generations to 1997.
- Decided
- Dec 16, 2020
- Review
- 240 days
- Class
- Class II
- Product code
- QEH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K965017 (1997). 20 ancestors in all, the oldest K801343 (1980). No later device cites it as a predicate yet.
- Root · 4 generations backK965017 Regional Anesthesia TraysSmiths Industries Medical Systems, Inc. · 1997 · Recalled
- 3 generations backK092657 Epifuse Catheter Connector, Model: 4909ESmiths Medical Asd, Inc. · 2009
- 2 generations backK110053 Correctinject Safety System, Catheter Connector, Filter, Infusion…Smiths Medical Asd, Inc. · 2012
- 1 generation backK170900 DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe +…Intervene Group, Ltd. · 2017
- This deviceK201031 NRFit® Caps, Male and Female Neuraxial Tip CapsInternational Medical Industries, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K965017 | Regional Anesthesia Trays | Smiths Industries Medical Systems, Inc. | 1997 | 7 |
| −3 | K092657 | Epifuse Catheter Connector, Model: 4909E | Smiths Medical Asd, Inc. | 2009 | — |
| −2 | 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 | — |
| 0 (this device) | K201031 | NRFit® Caps, Male and Female Neuraxial Tip Caps | International Medical Industries, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1982 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 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 QEH? 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 QEH device
- #1 K241385 Omnifix Syringe NRFitscore 8.9 · 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 |
|---|---|---|---|
| * | K170900 | DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe + Accessories, DASH 6…Summary page 5…Class II Classification Panel: General Hospital 5. Legally Marketed Predicate Device(s) Predicate Device K170900 Trade/Proprietary Name: DASH 6® NRFit Syringe Cap Common/Usual Name: syringe, Piston Classification Na… | 2017 |
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 23 years and passes through 4 companies; a new generation was cleared every 5.2 years on median.
- 5 of the 20 ancestors have a recall of any class.
How does its category compare?
All QEH devicesQEH Piston Syringe With Neuraxial Connector – Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · QEH
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · QEH
Too few QEH 510(k)s in any year since 2007 to give a median.
Recalls per year · QEH
No recall names QEH since 2007.
Adverse event reports per year · QEH
5in 2025
MAUDE reports naming product code QEH, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 1 | — | 0 | 13 |
| 2025 | 0 | — | 0 | 5 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The NRFit® cap is a sterile, single-use device intended to provide positive closure to prevent fluid loss and contamination
in Neuraxial devices CADD Cassettes or Syringes utilizing NRFit® connections. The NRFit® cap is intended to be used
for less than 24 hours on any single application.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201031 · printed Nov 3, 2026
Cite this page
510(k) Report. “K201031: NRFit® Caps, Male and Female Neuraxial Tip Caps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K201031
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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