510(k) Report

510(k) · Cleared

Cleared

Introducer Sheath (PFlexi00L065, PFlexi00L070, PFlexi00L075, PFlexi00L080, PFlexi00L090, PFlexi30L065, PFlexi30L070, PFlexi30L075, PFlexi30L080, PFlexi30L090, PFlexi45L065, PFlexi45L070, PFlexi45L075, PFlexi45L080, PFlexi45L090, PFlexi60L065, PFlexi60L070, PFlexi60L075, PFlexi60L080, PFlexi60L090)

K242756510(k) TraditionalCleared Nov 8, 202457-day reviewClass II21 CFR 870.1340

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

Pulnovo Medical (Wuxi) Co., Ltd. · DYB Introducer, Catheter

Cleared on Nov 8, 2024 as substantially equivalent to K210627 (Oscor, Inc., 2021) after a 57-day review. Its family tree reaches back 6 generations to 1993.

Decided
Nov 8, 2024
Review
57 days
Class
Class II
Product code
DYB
Recalls
None
Predicates
1

Its longest line of descent runs back 6 generations to K924607 (1993). 9 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2008: 1 other ancestor1998: 1 other ancestor2001: 1 other ancestorReference device: K172995 · Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination Renal Guiding Sheath · Terumo Medical Corporation · 2017K924607 · Arrow Fischell Kink Resist Percut Sheath Intro Set · Arrow Intl., Inc. · 1993 · recalledK012812 · Carotid Guiding Sheath · Terumo Medical Corp. · 2001 · recalledK051601 · Pinnacle Destination Peripheral Guiding Sheath · Terumo Medical Corp. · 2005K081341 · Reinforced Catheter Introducer System (Rcis) · Thomas Medical Products, Inc. · 2008K122958 · Delivery Sheath, Model Adelante Breezeway · Oscor, Inc. · 2012 · recalledK210627 · Breezeway II · Oscor, Inc. · 202119901995200020052010201520202025
Other ancestors, by generation 3 generations back: 2 other ancestors4 generations back: 1 other ancestor K210627 · Breezeway II · Oscor, Inc. · 2021K122958 · Delivery Sheath, Model Adelante Breezeway · Oscor, Inc. · 2012 · recalledK081341 · Reinforced Catheter Introducer System (Rcis) · Thomas Medical Products, Inc. · 2008K051601 · Pinnacle Destination Peripheral Guiding Sheath · Terumo Medical Corp. · 2005K012812 · Carotid Guiding Sheath · Terumo Medical Corp. · 2001 · recalledK924607 · Arrow Fischell Kink Resist Percut Sheath Intro Set · Arrow Intl., Inc. · 1993 · recalled−50
  1. Root · 6 generations backK924607 Arrow Fischell Kink Resist Percut Sheath Intro SetArrow Intl., Inc. · 1993 · Recalled
  2. 5 generations backK012812 Carotid Guiding SheathTerumo Medical Corp. · 2001 · Recalled
  3. 4 generations backK051601 Pinnacle Destination Peripheral Guiding SheathTerumo Medical Corp. · 2005
  4. 3 generations backK081341 Reinforced Catheter Introducer System (Rcis)Thomas Medical Products, Inc. · 2008
  5. 2 generations backK122958 Delivery Sheath, Model Adelante BreezewayOscor, Inc. · 2012 · Recalled
  6. 1 generation backK210627 Breezeway IIOscor, Inc. · 2021
  7. This deviceK242756 Introducer Sheath (PFlexi00L065, PFlexi00L070, PFlexi00L075…Pulnovo Medical (Wuxi) Co., Ltd. · 2024
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K924607Arrow Fischell Kink Resist Percut Sheath Intro SetArrow Intl., Inc.19933
−5K012812Carotid Guiding SheathTerumo Medical Corp.20011
−4K051601Pinnacle Destination Peripheral Guiding SheathTerumo Medical Corp.2005—
−3K081341Reinforced Catheter Introducer System (Rcis)Thomas Medical Products, Inc.2008—
−2K122958Delivery Sheath, Model Adelante BreezewayOscor, Inc.201230
−1K210627Breezeway IIOscor, Inc.2021—
0 (this device)K242756Introducer Sheath (PFlexi00L065, PFlexi00L070, PFlexi00L075, PFlexi00L080…Pulnovo Medical (Wuxi) Co., Ltd.2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810
200110
200810
FIG. 1 — Lineage of K242756, 1993–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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 DYB? 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 DYB device

  1. #1 K251051 AuST Steerable Sheathscore 18.0 · 10 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K210627Breezeway II
Summary page 5
…870.1340 Regulatory Class: Class II Product code: DYB Review Panel Cardiovascular III Predicate Device Predicate device 510(k) Number: K210627 Product Code: DYB 1…
Oscor, Inc.2021—
†K172995Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination…Terumo Medical Corporation2017—

What descends from it?

No later submission names this one as a predicate yet.

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 31 years and passes through 5 companies; a new generation was cleared every 4.6 years on median.
  • 4 of the 9 ancestors have a recall of any class.

How does its category compare?

All DYB devices

DYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.

FDA decisions per year · DYB

16in 2025

2007: 122008: 172009: 142010: 182011: 172012: 222013: 262014: 302015: 172016: 192017: 242018: 192019: 182020: 92021: 122022: 132023: 152024: 182025: 162026 (partial year): 17
2007high 30 (2014) · low 9 (2020)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DYB

63in 2025

2007: 95 days median2008: 37 days median2009: 52 days median2010: 123 days median2011: 100 days median2012: 128 days median2013: 118 days median2014: 122 days median2015: 129 days median2016: 95 days median2017: 70 days median2018: 156 days median2019: 47 days median2020: 49 days median2021: 78 days median2022: 143 days median2023: 55 days median2024: 56 days median2025: 63 days median2026 (partial year): 59 days median
2007high 156 (2018) · low 37 (2008)2026

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

Recalls per year · DYB

3in 2025

2007: 152008: 92009: 252010: 182011: 42012: 32013: 5, 1 Class I2014: 22015: 2, 1 Class I2016: 45, 3 Class I2017: 22, 1 Class I2018: 12019: 22020: 21, 21 Class I2021: 62022: 22023: 102024: 22025: 32026 (partial year): 23, 21 Class I
2007high 45 (2016) · low 1 (2018)2026

Class I (48 since 2007) Class II/III not classified

Adverse event reports per year · DYB

4,539in 2025

2007: 3162008: 4232009: 3992010: 4452011: 6282012: 8982013: 7432014: 7802015: 9132016: 1,2342017: 1,6722018: 1,9032019: 2,4502020: 2,4652021: 2,8352022: 4,0842023: 3,7752024: 3,9312025: 4,539
2007high 4,539 (2025) · low 316 (2007)2025

MAUDE reports naming product code DYB, 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
2007129515316
200817379423
2009145225399
20101812318445
2011171004628
2012221283898
2013261185 (1)743
2014301222780
2015171292 (1)913
2016199545 (3)1,234
2017247022 (1)1,672
20181915611,903
2019184722,450
202094921 (21)2,465
2021127862,835
20221314324,084
20231555103,775
2024185623,931
2025166334,539
2026175923 (21)—

What is it indicated for?

The Introducer Sheath is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements.

Do not use this device for neural placements.

Indications for use as stated in the FDA summary.

Recent decisions in DYB

The DYB category page

  • K262674Giranel Guiding Sheath SetKossel Medtech (Suzhou) Co., Ltd. · 2026
  • K253526NAMIC Dilator and SheathMedline Industries, LP · 2026
  • K261529Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit /…Hartman Medical Group, LLC · 2026
  • K261242SimplGuidePendracare · 2026
  • K261950Health Line Tearaway IntroducerHealth Line International Corporation · 2026

https://510kreport.com/device/K242756 · printed Nov 6, 2026

Cite this page

510(k) Report. “K242756: Introducer Sheath (PFlexi00L065, PFlexi00L070, PFlexi00L075, PFlexi00L080, PFlexi00L090, PFlexi30L065, PFlexi30L070, PFlexi30L075, PFlexi30L080, PFlexi30L090, PFlexi45L065, PFlexi45L070, PFlexi45L075, PFlexi45L080, PFlexi45L090, PFlexi60L065, PFlexi60L070, PFlexi60L075, PFlexi60L080, PFlexi60L090).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242756

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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