510(k) · Cleared
ClearedShelhigh NO-React Pneumopledgets
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shelhigh, Inc. · FTL Mesh, Surgical, Polymeric
Cleared on Aug 5, 1998 as substantially equivalent to K940205 (Bio-Vascular, Inc., 1994) and 2 other predicates after a 79-day review. Its family tree reaches back 2 generations to 1997. 1 later device descends from it.
- Decided
- Aug 5, 1998
- Review
- 79 days
- Class
- Class II
- Product code
- FTL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K964467 (1997). 3 ancestors in all, the oldest K940205 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK964467 Shelhigh Pericardial PatchShelhigh, Inc. · 1997
- 1 generation backK974914 Shelhigh NO-React Pericardial PatchesShelhigh, Inc. · 1998
- This deviceK981756 Shelhigh NO-React PneumopledgetsShelhigh, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK991567 Shelhigh NO-React Tissue Repair Patch/Uropatch.Shelhigh, Inc. · 1999
Most influential descendants
Showing 1 of 1 · See all- K991567Shelhigh NO-React Tissue Repair Patch/Uropatch.Shelhigh, Inc. · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K964467 | Shelhigh Pericardial Patch | Shelhigh, Inc. | 1997 | — |
| −1 | K974914 | Shelhigh NO-React Pericardial Patches | Shelhigh, Inc. | 1998 | — |
| 0 (this device) | K981756 | Shelhigh NO-React Pneumopledgets | Shelhigh, Inc. | 1998 | — |
| +1 | K991567 | Shelhigh NO-React Tissue Repair Patch/Uropatch. | Shelhigh, Inc. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 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.
Planning a device in FTL? 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 FTL device
- #1 K220091 Poly-Tape/Infinity-Lock Soft Tissue…score 16.8 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K940205 | Peri-Strips Our OCR of the scanned summary read K340205, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Peri-Strips®”. | 1994 |
| * | K974914 | Shelhigh NO-React Pericardial Patches Cleared while this submission was under review Summary page 2…l Equivalence The Shelhigh No-React® PneumoPledgets. is equivalent to the Peri-Strips® manufactured by Bio-Vascular K340205 and the Shelhigh No-React® pericardial patch K974914 and #K964467 currently manufactured by Shethigh Inc. VI. Comparison with Predicate Device ~, The Shelhigh No-React® PneumoPle… | 1998 |
| * | K964467 | Shelhigh Pericardial PatchSummary page 2…The Shelhigh No-React® PneumoPledgets. is equivalent to the Peri-Strips® manufactured by Bio-Vascular K340205 and the Shelhigh No-React® pericardial patch K974914 and #K964467 currently manufactured by Shethigh Inc. VI. Comparison with Predicate Device ~, The Shelhigh No-React® PneumoPledgets. like t… | 1997 |
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 |
|---|---|---|---|
| K991567 | Shelhigh NO-React Tissue Repair Patch/Uropatch. | 1999 | 0 |
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 1 year and passes through 1 company; a new generation was cleared every 8 months on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K991567 (Shelhigh, Inc., 1999) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K940205.
How does its category compare?
All FTL devicesFTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FTL
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FTL
30in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FTL
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FTL
3,487in 2025
MAUDE reports naming product code FTL, 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 | 20 | 92 | 2 | 1,737 |
| 2008 | 23 | 114 | 1 | 1,569 |
| 2009 | 15 | 97 | 1 | 1,906 |
| 2010 | 18 | 132 | 12 | 2,175 |
| 2011 | 15 | 90 | 8 | 3,608 |
| 2012 | 12 | 213 | 2 | 14,700 |
| 2013 | 8 | 90 | 1 | 26,519 |
| 2014 | 11 | 70 | 3 | 2,683 |
| 2015 | 12 | 121 | 0 | 2,526 |
| 2016 | 3 | 186 | 0 | 2,417 |
| 2017 | 6 | 132 | 1 | 3,947 |
| 2018 | 12 | 105 | 1 | 11,893 |
| 2019 | 4 | 99 | 0 | 21,724 |
| 2020 | 5 | 138 | 1 | 18,819 |
| 2021 | 2 | — | 0 | 16,284 |
| 2022 | 6 | 195 | 0 | 11,439 |
| 2023 | 4 | 29 | 0 | 8,025 |
| 2024 | 2 | — | 0 | 8,565 |
| 2025 | 6 | 30 | 0 | 3,487 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The device is intended for use to reinforced the soft tissue of the lung, thereby sealing or reducing air leak that occur during pulmonary surgery.
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/K981756 · printed Nov 5, 2026
Cite this page
510(k) Report. “K981756: Shelhigh NO-React Pneumopledgets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K981756
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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