510(k) · Cleared
Recalled · Class III · 2019Edi Catheter ENFit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Maquet Critical Care AB · PIF Gastrointestinal Tubes With Enteral Specific Connectors
Cleared on Mar 2, 2017 as substantially equivalent to K123149 (Maquet Critical Care AB, 2014) after a 435-day review. Its family tree reaches back 12 generations to 1991. 5 of the 65 devices in its family, counting itself, have a Class I recall. 1 later device descends from it. It has been recalled once.
- Decided
- Mar 2, 2017
- Review
- 435 days
- Class
- Class II
- Product code
- PIF
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 12 generations to K902859 (1991). 63 ancestors in all, the oldest K883038 (1988). 1 later device descends from it, 1 citing it directly. 5 of the 65 devices in this family, counting this one, have a Class I recall.
- Root · 12 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 8 generations between
- 3 generations backK063404 Servo-I Ventilator System, Models 64, 87 and 800Maquet Critical Care AB · 2007
- 2 generations backK073179 Servo-I Ventilator System Model 64 87 800 E4073, Heliox Option…Maquet Critical Care AB · 2008
- 1 generation backK123149 Servo-I Ventilator SystemMaquet Critical Care AB · 2014 · Recalled
- This deviceK153688 Edi Catheter ENFitMaquet Critical Care AB · 2017
- Descendant · cites it directly · 0 of its ownK253715 Edi Catheter ENFit 6Fr/48 cm (6893166); Edi Catheter ENFit 6Fr/49cm…Maquet Critical Care AB · 2026
Show all 12 generations
- Root · 12 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 11 generations backK960010 Servo Ventilator 300 Computer InterfaceSiemens Elema AB · 1996
- 10 generations backK970839 Servo Ventilator 300ASiemens Elema AB · 1997 · Recalled
- 9 generations backK992788 Bear Cub 750 PSVBear Medical Systems, Inc. · 1999
- 8 generations backK013642 AVEABird Products Corp. · 2002 · Recalled (Class I)
- 7 generations backK032451 Bird Tbird Vela VentilatorBird Products Corp. · 2004 · Recalled
- 6 generations backK052554 Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc. · 2005
- 5 generations backK053270 IVENT 201Versamed Medical Systems, Inc. · 2006
- 4 generations backK061627 Modification to I Vent 201Versamed Medical Systems, Inc. · 2006
- 3 generations backK063404 Servo-I Ventilator System, Models 64, 87 and 800Maquet Critical Care AB · 2007
- 2 generations backK073179 Servo-I Ventilator System Model 64 87 800 E4073, Heliox Option…Maquet Critical Care AB · 2008
- 1 generation backK123149 Servo-I Ventilator SystemMaquet Critical Care AB · 2014 · Recalled
- This deviceK153688 Edi Catheter ENFitMaquet Critical Care AB · 2017
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K253715Edi Catheter ENFit 6Fr/48 cm (6893166); Edi Catheter ENFit 6Fr/49cm (6893273); Edi…Maquet Critical Care AB · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −11 | K960010 | Servo Ventilator 300 Computer Interface | Siemens Elema AB | 1996 | — |
| −10 | K970839 | Servo Ventilator 300A | Siemens Elema AB | 1997 | 4 |
| −9 | K992788 | Bear Cub 750 PSV | Bear Medical Systems, Inc. | 1999 | — |
| −8 | K013642 | AVEA | Bird Products Corp. | 2002 | Class I |
| −7 | K032451 | Bird Tbird Vela Ventilator | Bird Products Corp. | 2004 | 1 |
| −6 | K052554 | Modification to: Ivent 201 Portable Ventilator | Versamed Medical Systems, Inc. | 2005 | — |
| −5 | K053270 | IVENT 201 | Versamed Medical Systems, Inc. | 2006 | — |
| −4 | K061627 | Modification to I Vent 201 | Versamed Medical Systems, Inc. | 2006 | — |
| −3 | K063404 | Servo-I Ventilator System, Models 64, 87 and 800 | Maquet Critical Care AB | 2007 | — |
| −2 | K073179 | Servo-I Ventilator System Model 64 87 800 E4073, Heliox Option, Model 6675585 | Maquet Critical Care AB | 2008 | — |
| −1 | K123149 | Servo-I Ventilator System | Maquet Critical Care AB | 2014 | 2 |
| 0 (this device) | K153688 | Edi Catheter ENFit | Maquet Critical Care AB | 2017 | — |
| +1 | K253715 | Edi Catheter ENFit 6Fr/48 cm (6893166); Edi Catheter ENFit 6Fr/49cm (6893273)… | Maquet Critical Care AB | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1990 | 5 | 0 |
| 1991 | 4 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 7 | 2 |
| 1999 | 4 | 0 |
| 2000 | 3 | 1 |
| 2001 | 5 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 4 | 1 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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.
5 devices in this family have 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 PIF device
- #1 K253715 Edi Catheter ENFit 6Fr/48 cm (6893166); Edi…score 15.5 · 13 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 |
|---|---|---|---|
| * | K123149 | Servo-I Ventilator SystemSummary page 5…fication Legally marketed devices to which equivalence is being claimed 510(k) # SERVO-i Ventilator System K123149 Device Description The Edi Catheter ENFit is a sterile, single use nasogastric feeding tube that carries electrode rings that r… | 2014 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253715 | Edi Catheter ENFit 6Fr/48 cm (6893166); Edi Catheter ENFit 6Fr/49cm (6893273); Edi… | 2026 | 0 |
Has anything in its family been recalled? (5 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 20, 2019 | Class III | Z-1221-2019 | Under Investigation by firm | Edi Catheter labeled with wrong expiry date on single pack EDI catheter boxes |
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.
- K041223Modification to Servo-I Ventilator System, Model 64 87 800 E407EMaquet Critical Care AB · 2004 · 2 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
- K013642AVEABird Products Corp. · 2002 · 4 generations back · ◆ on the line of descent in FIG. 113 Class I recalls
- K001646Puritan-Bennett 840 Ventilator System with Neomode OptionPuritan Bennett Corp. · 2000 · 5 generations back · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
- K970460Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · 5 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K981072Esprit VentilatorRespironics, Inc. · 1998 · 7 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 26 years and passes through 6 companies; a new generation was cleared every 1.8 years on median.
- 18 of the 63 ancestors have a recall of any class; 5 have a Class I recall.
- Of its descendants, K253715 (Maquet Critical Care AB, 2026) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K123149.
How does its category compare?
All PIF devicesPIF Gastrointestinal Tubes With Enteral Specific Connectors: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · PIF
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PIF
242in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PIF
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PIF
83in 2025
MAUDE reports naming product code PIF, 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 | 3 | 119 | 0 | 0 |
| 2015 | 9 | 143 | 106 | 12 |
| 2016 | 3 | 267 | 0 | 45 |
| 2017 | 5 | 174 | 0 | 17 |
| 2018 | 2 | — | 0 | 17 |
| 2019 | 7 | 135 | 0 | 28 |
| 2020 | 4 | 165 | 0 | 70 |
| 2021 | 4 | 242 | 0 | 89 |
| 2022 | 4 | 167 | 0 | 77 |
| 2023 | 4 | 242 | 0 | 96 |
| 2024 | 2 | — | 1 | 110 |
| 2025 | 2 | — | 0 | 83 |
| 2026 | 3 | 239 | 0 | — |
What is it indicated for?
The Edi catheter ENFit is intended for:
Administrating nutrition, fluids and medications via the naso-gastro-enteric route
Aspiration via the naso-gastroenteric route
Transfers electrical activity (Edi signals) to compatible SERVO ventilator systems on which NAVA and NAVA NIV are available
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/K153688 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153688: Edi Catheter ENFit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153688
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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