510(k) Report

510(k) · Cleared

Recalled · Class II · 2025

IV Administration Set with Backcheck

K790062510(k) TraditionalCleared Apr 10, 197990-day reviewClass II21 CFR 880.5440Recalls 61

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

National Patent Development Corp. · FPA Set, Administration, Intravascular

Cleared on Apr 10, 1979 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it. It has been recalled 61 times.

Decided
Apr 10, 1979
Review
90 days
Class
Class II
Product code
FPA
Recalls
61
Predicates
0

2 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 1999: 1 descendant cleared2003: 1 descendant cleared19801990200020102020
  1. This deviceK790062 IV Administration Set with BackcheckNational Patent Development Corp. · 1979
  2. Descendant · cites it directly · 0 of its ownK033576 Lifeshield Latex-Free Primary IV Pump Set Distal Microbore Patient…Abbott Laboratories · 2003 · Recalled
  3. Descendant · cites it directly · 0 of its ownK983217 Rowe Dual-Check ValveCook, Inc. · 1999

Most influential descendants

Showing 2 of 2 · See all
  • K033576Lifeshield Latex-Free Primary IV Pump Set Distal Microbore Patient Line, Convertible…Abbott Laboratories · 2003 · cites it directly0descendants
  • K983217Rowe Dual-Check ValveCook, Inc. · 1999 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K790062IV Administration Set with BackcheckNational Patent Development Corp.1979—
+1K033576Lifeshield Latex-Free Primary IV Pump Set Distal Microbore Patient Line…Abbott Laboratories20036
+1K983217Rowe Dual-Check ValveCook, Inc.1999—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200310
FIG. 1 — Lineage of K790062, 1979–2003Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FPA? 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 FPA device

  1. #1 K243841 Sparta Infusion Set for Insulinscore 13.4 · 3 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K033576Lifeshield Latex-Free Primary IV Pump Set Distal Microbore Patient Line, Convertible…Abbott Laboratories20030
K983217Rowe Dual-Check ValveCook, Inc.19990

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Oct 29, 2025Class IIZ-0688-2026Process controlPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025Class IIZ-0687-2026Process controlPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025Class IIZ-0607-2026Process controlPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025Class IIZ-0661-2026Process controlPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025Class IIZ-0693-2026Process controlPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025Class IIZ-0671-2026Process controlPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025Class IIZ-0697-2026Process controlPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025Class IIZ-0658-2026Process controlPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025Class IIZ-0703-2026Process controlPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025Class IIZ-0660-2026Process controlPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025Class IIZ-0653-2026Process controlPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025Class IIZ-0699-2026Process controlPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025Class IIZ-0666-2026Process controlPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025Class IIZ-0668-2026Process controlPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025Class IIZ-0654-2026Process controlPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025Class IIZ-0691-2026Process controlPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025Class IIZ-0603-2026Process controlPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025Class IIZ-0683-2026Process controlPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025Class IIZ-0631-2026Process controlPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025Class IIZ-0696-2026Process controlPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025Class IIZ-0610-2026Process controlPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025Class IIZ-0692-2026Process controlPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025Class IIZ-0612-2026Process controlPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025Class IIZ-0695-2026Process controlPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025Class IIZ-0663-2026Process controlPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025Class IIZ-0627-2026Process controlPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025Class IIZ-0615-2026Process controlPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025Class IIZ-0665-2026Process controlPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025Class IIZ-0656-2026Process controlPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025Class IIZ-0652-2026Process controlPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025Class IIZ-0662-2026Process controlPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025Class IIZ-0667-2026Process controlPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025Class IIZ-0682-2026Process controlPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025Class IIZ-0625-2026Process controlPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025Class IIZ-0689-2026Process controlPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025Class IIZ-0672-2026Process controlPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025Class IIZ-0694-2026Process controlPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025Class IIZ-0657-2026Process controlPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025Class IIZ-0698-2026Process controlPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025Class IIZ-0604-2026Process controlPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025Class IIZ-0684-2026Process controlPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025Class IIZ-0624-2026Process controlPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025Class IIZ-0690-2026Process controlPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025Class IIZ-0685-2026Process controlPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025Class IIZ-0659-2026Process controlPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025Class IIZ-0614-2026Process controlPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025Class IIZ-0609-2026Process controlPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025Class IIZ-0613-2026Process controlPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025Class IIZ-0664-2026Process controlPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Oct 29, 2025Class IIZ-0626-2026Process controlPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

The 5 latest of 50 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K033576 (Abbott Laboratories, 2003) has gone furthest, with 0 descendants of its own.

How does its category compare?

All FPA devices

FPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FPA

11in 2025

2007: 162008: 182009: 102010: 232011: 122012: 212013: 132014: 222015: 172016: 122017: 172018: 42019: 72020: 102021: 132022: 142023: 142024: 72025: 112026 (partial year): 5
2007high 23 (2010) · low 4 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FPA

225in 2025

2007: 75 days median2008: 89 days median2009: 166 days median2010: 120 days median2011: 87 days median2012: 96 days median2013: 90 days median2014: 89 days median2015: 123 days median2016: 195 days median2017: 240 days median2018: 177 days median2019: 161 days median2020: 327 days median2021: 186 days median2022: 213 days median2023: 340 days median2024: 244 days median2025: 225 days median2026 (partial year): 266 days median
2007high 340 (2023) · low 75 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FPA

98in 2025

2007: 172008: 152009: 1662010: 582011: 282012: 16, 4 Class I2013: 642014: 242015: 62016: 102017: 132018: 42019: 132020: 1072021: 12022: 9, 5 Class I2023: 12, 4 Class I2024: 13, 1 Class I2025: 98, 1 Class I2026 (partial year): 10, 2 Class I
2007high 166 (2009) · low 1 (2021)2026

Class I (17 since 2007) Class II/III not classified

Adverse event reports per year · FPA

34,506in 2025

2007: 1,4992008: 1,9412009: 2,5122010: 2,5372011: 4,4072012: 4,9302013: 4,6512014: 4,6952015: 6,6252016: 8,4702017: 6,4622018: 6,5742019: 11,2272020: 9,5632021: 10,4142022: 13,3932023: 10,9162024: 47,2102025: 34,506
2007high 47,210 (2024) · low 1,499 (2007)2025

MAUDE reports naming product code FPA, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071675171,499
20081889151,941
2009101661662,512
201023120582,537
20111287284,407
2012219616 (4)4,930
20131390644,651
20142289244,695
20151712366,625
201612195108,470
201717240136,462
2018417746,574
201971611311,227
2020103271079,563
202113186110,414
2022142139 (5)13,393
20231434012 (4)10,916
2024724413 (1)47,210
20251122598 (1)34,506
2026526610 (2)—

More from National Patent Development Corp.

34 FDA decisions under this applicant name. See the company

  • K843974Variable Temperature Cautery DeviceNational Patent Development Corp. · 1985
  • K832699Hydron Wound Dressing Fast Seat KitNational Patent Development Corp. · 1984
  • K822793Pio Root Canal IndicatorNational Patent Development Corp. · 1982
  • K820028Zeon Composite Resin Light Cure SysNational Patent Development Corp. · 1982
  • K820006Zeon Composite Resin SystemNational Patent Development Corp. · 1982

Recent decisions in FPA

The FPA category page

  • K260261Gravity Blood Sets with 200µm FilterB.Braun Medical, Inc. · 2026
  • K254123Ecomed Disposable Administration SetsEcomed Solutions, LLC · 2026
  • K261530iiSure Infusion SetDeka Research and Development · 2026
  • K252543AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF…Amsino International, Inc. · 2026
  • K251375PuraCath Firefly Needleless Connector IT (9005)Puracath Medical, Inc. · 2026

https://510kreport.com/device/K790062 · printed Nov 4, 2026

Cite this page

510(k) Report. “K790062: IV Administration Set with Backcheck.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K790062

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026