510(k) · Cleared
ClearedArtiglass NRFitTM Tip L.O.R. Glass Syringes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Artiglass Srl · QEH Piston Syringe With Neuraxial Connector – Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact
Cleared on May 19, 2022 as substantially equivalent to K122416 (Artiglass Srl, 2013) after a 164-day review. Its family tree reaches back 2 generations to 2008.
- Decided
- May 19, 2022
- Review
- 164 days
- Class
- Class II
- Product code
- QEH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K082674 (2008). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K082674 | Spectra-Glass Lor (Loss of Resistance Syringe, 5CC Metal L/S or L/L Tip… | Spectra Medical Devices, Inc. | 2008 | — |
| −1 | K122416 | Artiglass L. O.R. Glass Syringe | Artiglass Srl | 2013 | — |
| 0 (this device) | K213800 | Artiglass NRFitTM Tip L.O.R. Glass Syringes | Artiglass Srl | 2022 | — |
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 |
|---|---|---|---|
| * | K122416 | Artiglass L. O.R. Glass SyringeSummary page 4…FitTM Tip L.O.R. Glass Syringes Generic/Common Name: NRFitTM Tip L.O.R. Glass Syringes Predicate device Predicate Device: Artiglass L.O.R. Glass Syringes 510(k) Number: K122416 510(k) Clearance Date: May 3, 2013 Regulation Number: 21 CFR § 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Prod… | 2013 |
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 14 years and passes through 2 companies; a new generation was cleared every 9.0 years on median.
- None of the 2 ancestors has a recall.
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. 2022, 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 Artiglass NRFit tip Glass 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 as explained in standard textbooks. These syringes are not intended for injection or aspiration.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213800 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213800: Artiglass NRFitTM Tip L.O.R. Glass Syringes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213800
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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