510(k) · Cleared
ClearedOral/Enteral Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ningbo Tianyi Medical Appliance Co., Ltd. · PNR Enteral Syringes With Enteral Specific Connectors
Cleared on Apr 28, 2021 as substantially equivalent to K122373 (Neomed, Inc., 2012) after a 57-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- Apr 28, 2021
- Review
- 57 days
- Class
- Class II
- Product code
- PNR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K951871 (1995). No later device cites it as a predicate yet.
- Root · 3 generations backK951871 Piston SyringeBaxa Corp. · 1995
- 2 generations backK092908 Neomed Sterile Syringe, Models SD-S1EO, SD-S3EO, SD-S630, SD-S12EO…Neomed, Inc. · 2010
- 1 generation backK122373 Neomed Oral/Enteral SyringeNeomed, Inc. · 2012
- This deviceK210621 Oral/Enteral SyringeNingbo Tianyi Medical Appliance Co., Ltd. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K951871 | Piston Syringe | Baxa Corp. | 1995 | — |
| −2 | K092908 | Neomed Sterile Syringe, Models SD-S1EO, SD-S3EO, SD-S630, SD-S12EO, SD-S20EO… | Neomed, Inc. | 2010 | — |
| −1 | K122373 | Neomed Oral/Enteral Syringe | Neomed, Inc. | 2012 | — |
| 0 (this device) | K210621 | Oral/Enteral Syringe | Ningbo Tianyi Medical Appliance Co., Ltd. | 2021 | — |
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 PNR? 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 PNR device
- #1 K252483 Enteral Syringe (20ml, 60ml)score 14.0 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K192179 | Oral/Enteral Syringe Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 6…210621 the device during the shelf life of three years. 5. Identification of Predicate Device Primary Predicate Device 510(k) Number: K192179 Trade Name: Oral/Enteral Syringe Secondary Predicate Device 510(k) Number: K122373 Product Name… | |
| * | K122373 | Neomed Oral/Enteral SyringeSummary page 6…ce Primary Predicate Device 510(k) Number: K192179 Trade Name: Oral/Enteral Syringe Secondary Predicate Device 510(k) Number: K122373 Product Name: NeoMed Oral/Enteral Syringe (0.5ml to 100ml) 6. Non-Clinical Test Conclusion Non clinical te… | 2012 |
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 26 years and passes through 3 companies; a new generation was cleared every 8.6 years on median.
- None of the 3 ancestors has a recall.
- 2 other devices also cite its predicate K122373.
How does its category compare?
All PNR devicesPNR Enteral Syringes With Enteral Specific Connectors: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · PNR
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PNR
129in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PNR
4in 2023
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · PNR
7in 2025
MAUDE reports naming product code PNR, 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 | 3 | 139 | 0 | 0 |
| 2016 | 6 | 65 | 0 | 1 |
| 2017 | 5 | 247 | 0 | 3 |
| 2018 | 3 | 133 | 0 | 2 |
| 2019 | 2 | — | 0 | 8 |
| 2020 | 3 | 209 | 0 | 3 |
| 2021 | 5 | 129 | 0 | 5 |
| 2022 | 2 | — | 0 | 2 |
| 2023 | 2 | — | 4 (4) | 11 |
| 2024 | 1 | — | 0 | 34 |
| 2025 | 1 | — | 0 | 7 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The device is indicated for use as a dispenser, a measuring device and an oral fluid transfer device. It is intended to be used to deliver fluids into the body orally or enterally. It is intended to be used in clinical or home care settings by operators ranging from qualified medical practitioners to laypersons (under the supervision of a qualified medical practitioners) in all age groups.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210621 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210621: Oral/Enteral Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210621
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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