510(k) · Cleared
Recalled · 2003Lifeshield Primary I.V. Set with Backcheck Valve
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Mfg., Inc. · FPA Set, Administration, Intravascular
Cleared on Jun 27, 1997 after an 81-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it. It has been recalled once.
- Decided
- Jun 27, 1997
- Review
- 81 days
- Class
- Class II
- Product code
- FPA
- Recalls
- 1
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK971293 Lifeshield Primary I.V. Set with Backcheck ValveAbbott Mfg., Inc. · 1997
- Descendant · cites it directly · 0 of its ownK033576 Lifeshield Latex-Free Primary IV Pump Set Distal Microbore Patient…Abbott Laboratories · 2003 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K033576Lifeshield Latex-Free Primary IV Pump Set Distal Microbore Patient Line, Convertible…Abbott Laboratories · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K971293 | Lifeshield Primary I.V. Set with Backcheck Valve | Abbott Mfg., Inc. | 1997 | — |
| +1 | K033576 | Lifeshield Latex-Free Primary IV Pump Set Distal Microbore Patient Line… | Abbott Laboratories | 2003 | 6 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), 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 K243841 Sparta Infusion Set for Insulinscore 13.4 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
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 |
|---|---|---|---|
| K033576 | Lifeshield Latex-Free Primary IV Pump Set Distal Microbore Patient Line, Convertible… | 2003 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 9, 2003 | Not classified | Z-0957-03 | Other | The drip chambers and/or adapters in the sets were manufactured with non-radiation grade plastic resin, resulting in discoloration of the resin. |
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 devicesFPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FPA
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FPA
225in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FPA
98in 2025
Class I (17 since 2007) Class II/III not classified
Adverse event reports per year · FPA
34,506in 2025
MAUDE reports naming product code FPA, 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 | 16 | 75 | 17 | 1,499 |
| 2008 | 18 | 89 | 15 | 1,941 |
| 2009 | 10 | 166 | 166 | 2,512 |
| 2010 | 23 | 120 | 58 | 2,537 |
| 2011 | 12 | 87 | 28 | 4,407 |
| 2012 | 21 | 96 | 16 (4) | 4,930 |
| 2013 | 13 | 90 | 64 | 4,651 |
| 2014 | 22 | 89 | 24 | 4,695 |
| 2015 | 17 | 123 | 6 | 6,625 |
| 2016 | 12 | 195 | 10 | 8,470 |
| 2017 | 17 | 240 | 13 | 6,462 |
| 2018 | 4 | 177 | 4 | 6,574 |
| 2019 | 7 | 161 | 13 | 11,227 |
| 2020 | 10 | 327 | 107 | 9,563 |
| 2021 | 13 | 186 | 1 | 10,414 |
| 2022 | 14 | 213 | 9 (5) | 13,393 |
| 2023 | 14 | 340 | 12 (4) | 10,916 |
| 2024 | 7 | 244 | 13 (1) | 47,210 |
| 2025 | 11 | 225 | 98 (1) | 34,506 |
| 2026 | 5 | 266 | 10 (2) | — |
What is it indicated for?
The Primary .V. Set with Backcheck Valve is used for the delivery of
1.V. fluids through the primary line or through the attachment of a
secondary line iriio the backcheck valve. A backcheck valve prevents
the intermixing of fluids while the secondary line is running. Then, when
the secondary line is emptied, the valve automatically restores flow from
the primary container.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K971293 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971293: Lifeshield Primary I.V. Set with Backcheck Valve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971293
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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