510(k) · Cleared
ClearedOral/Enteral Syringes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Children'S Medical Ventures · FPD Tube, Feeding
Cleared on Jun 14, 2010 as substantially equivalent to K060944 (Vygon Corp., 2006) and 1 other predicate after a 152-day review. Its family tree reaches back 3 generations to 1980. 1 of the 46 devices in its family, counting itself, has a Class I recall. 35 later devices descend from it.
- Decided
- Jun 14, 2010
- Review
- 152 days
- Class
- Class II
- Product code
- FPD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K801558 (1980). 10 ancestors in all. 35 later devices descend from it, 2 citing it directly. 1 of the 46 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK801558 Enteric Feeding Tube W/Segm. Flex. WT.Biosearch Medical Products, Inc. · 1980
- 2 generations backK973409 Kangaroo Enteral Feeding Extension Set for Syringe PumpsDavis & Geck, Inc. · 1998
- 1 generation backK082654 Enteral Only Extension SetRespironics, Inc. · 2008
- This deviceK100099 Oral/Enteral SyringesPhilips Children'S Medical Ventures · 2010
- Descendant · cites it directly · 33 of its ownK112434 BD Oral/Enteral Syringe with BD Univia ConnectionBd Medical Surgical · 2011
- Descendant · 2 generations on · 31 of its ownK142128 Kangaroo Enteral Feeding Syringes with Enfit ConnectorCovidien · 2015
- Descendant · 3 generations on · 30 of its ownK152857 NeoMed NeoConnect Enteral Syringes with ENFit Connector and…Neomed, Inc. · 2015
- Descendant · 4 generations on · 21 of its ownK161039 NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100…Neomed, Inc. · 2016
- Descendant · 5 generations on · 5 of its ownK183540 Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low…Neomed, Inc. · 2019
Showing 5 of 35 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K190502 ENFit Oral / Enteral Syringe5 generations on · 2019
Most influential descendants
Showing 5 of 35 · See all- K112434BD Oral/Enteral Syringe with BD Univia ConnectionBd Medical Surgical · 2011 · cites it directly33descendants
- K142128Kangaroo Enteral Feeding Syringes with Enfit ConnectorCovidien · 2015 · 2 generations on31descendants
- K152857NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible NeoSecure Tip CapsNeomed, Inc. · 2015 · 3 generations on30descendants
- K161039NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and NeoConnect…Neomed, Inc. · 2016 · 4 generations on21descendants
- K183540Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low Dose Tip Oral/Enteral…Neomed, Inc. · 2019 · 5 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K801558 | Enteric Feeding Tube W/Segm. Flex. WT. | Biosearch Medical Products, Inc. | 1980 | — |
| −2 | K973409 | Kangaroo Enteral Feeding Extension Set for Syringe Pumps | Davis & Geck, Inc. | 1998 | — |
| −1 | K082654 | Enteral Only Extension Set | Respironics, Inc. | 2008 | — |
| 0 (this device) | K100099 | Oral/Enteral Syringes | Philips Children'S Medical Ventures | 2010 | — |
| +1 | K112434 | BD Oral/Enteral Syringe with BD Univia Connection | Bd Medical Surgical | 2011 | — |
| +2 | K142128 | Kangaroo Enteral Feeding Syringes with Enfit Connector | Covidien | 2015 | — |
| +3 | K152857 | NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible… | Neomed, Inc. | 2015 | — |
| +4 | K161039 | NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and… | Neomed, Inc. | 2016 | — |
| +5 | K183540 | Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low Dose Tip… | Neomed, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 2 | 0 |
| 1983 | 1 | 0 |
| 1992 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 7 | 0 |
| 2017 | 4 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 1 |
| 2020 | 3 | 0 |
| 2021 | 4 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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 FPD device
- #1 K243361 Nutrifitscore 8.8 · 2 generations · no Class I recall
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K060944 | Nutrisafe 2Summary page 1…FPD Predicate Devices Vygon Corp. Nutrisafe 2 System Transparent Syringes (K060944) Respironics, Inc. Enteral Only Extension Set (K082654) Intended Use/indications fo… | 2006 |
| * | K082654 | Enteral Only Extension SetSummary page 1…System Transparent Syringes (K060944) Respironics, Inc. Enteral Only Extension Set (K082654) Intended Use/indications for Use The Oral/Enteral Syringes is intended for the delivery of liquid medication, formula. and b… | 2008 |
What descends from it? (35)
See all 352 later devices cite it directly; ranked here by how many devices descend from each in turn.
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.
- K190502ENFit Oral / Enteral SyringeJiangsu Caina Medical Co.,Ltd · 2019 · 5 generations on · ◆ in the 2019 descendants bar of FIG. 14 Class I recalls
What does this lineage say?
- The line of descent spans 30 years and passes through 4 companies; a new generation was cleared every 10.7 years on median.
- 2 of the 10 ancestors have a recall of any class.
- Of its descendants, K112434 (Bd Medical Surgical, 2011) has gone furthest, with 33 descendants of its own.
- 6 other devices also cite its predicate K060944.
How does its category compare?
All FPD devicesFPD Tube, Feeding: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · FPD
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · FPD
118in 2010
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FPD
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FPD
10in 2025
MAUDE reports naming product code FPD, 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 | 1 | — | 0 | 19 |
| 2008 | 4 | 76 | 0 | 24 |
| 2009 | 4 | 69 | 0 | 40 |
| 2010 | 4 | 118 | 0 | 21 |
| 2011 | 2 | — | 0 | 15 |
| 2012 | 1 | — | 0 | 32 |
| 2013 | 2 | — | 0 | 38 |
| 2014 | 0 | — | 0 | 64 |
| 2015 | 0 | — | 1 | 55 |
| 2016 | 0 | — | 0 | 102 |
| 2017 | 0 | — | 0 | 34 |
| 2018 | 0 | — | 3 | 30 |
| 2019 | 1 | — | 1 | 19 |
| 2020 | 0 | — | 0 | 31 |
| 2021 | 0 | — | 0 | 24 |
| 2022 | 0 | — | 0 | 19 |
| 2023 | 0 | — | 0 | 55 |
| 2024 | 1 | — | 0 | 41 |
| 2025 | 0 | — | 0 | 10 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Oral/Enteral Syringes are intended for the delivery of liquid medication, formula,
and breast milk.
The patient population is neonates and infants. The environments for use are
hospital and home environments by trained caregivers only. The Oral/Enteral
Syringes are disposable and for single patient use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100099 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100099: Oral/Enteral Syringes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100099
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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