510(k) Report

510(k) · Cleared

Cleared

Plastic Attachable Dual Port

K912702510(k) TraditionalCleared Sep 18, 199191-day reviewClass II21 CFR 880.5965

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

Davol, Inc. · LJT Port & Catheter, Implanted, Subcutaneous, Intravascular

Cleared on Sep 18, 1991 after a 91-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 4 later devices descend from it.

Decided
Sep 18, 1991
Review
91 days
Class
Class II
Product code
LJT
Recalls
None
Predicates
0

4 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2003: 1 descendant cleared2014: 1 descendant cleared1997: 1 descendant cleared2004: 1 descendant cleared1990200020102020
  1. This deviceK912702 Plastic Attachable Dual PortDavol, Inc. · 1991
  2. Descendant · cites it directly · 2 of its ownK032044 X-Prot Duo PortC.R. Bard, Inc. · 2003
  3. Descendant · cites it directly · 0 of its ownK133335 Powerport Implantable PortC.R. Bard, Inc. · 2014
  4. Descendant · 2 generations on · 0 of its ownK034065 Modification to X-Port Duo PortC.R. Bard, Inc. · 2004
  5. Descendant · cites it directly · 0 of its ownK964066 Dual Slim Port Implanted Port (0654970/0654940)C.R. Bard, Inc. · 1997

Most influential descendants

Showing 4 of 4 · See all
  • K032044X-Prot Duo PortC.R. Bard, Inc. · 2003 · cites it directly2descendants
  • K133335Powerport Implantable PortC.R. Bard, Inc. · 2014 · cites it directly0descendants
  • K034065Modification to X-Port Duo PortC.R. Bard, Inc. · 2004 · 2 generations on0descendants
  • K964066Dual Slim Port Implanted Port (0654970/0654940)C.R. Bard, Inc. · 1997 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K912702Plastic Attachable Dual PortDavol, Inc.1991—
+1K032044X-Prot Duo PortC.R. Bard, Inc.2003—
+1K133335Powerport Implantable PortC.R. Bard, Inc.2014—
+2K034065Modification to X-Port Duo PortC.R. Bard, Inc.2004—
+1K964066Dual Slim Port Implanted Port (0654970/0654940)C.R. Bard, Inc.1997—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
200310
200410
201410
FIG. 1 — Lineage of K912702, 1991–2014Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LJT? 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 LJT device

  1. #1 K251253 PowerPort™ isp Implantable Port; PowerPort™…score 14.9 · 9 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (4)

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

NumberDeviceApplicantDecidedDescendants
K032044X-Prot Duo PortC.R. Bard, Inc.20032
K133335Powerport Implantable PortC.R. Bard, Inc.20140
K964066Dual Slim Port Implanted Port (0654970/0654940)C.R. Bard, Inc.19970

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?

  • Of its descendants, K032044 (C.R. Bard, Inc., 2003) has gone furthest, with 2 descendants of its own.

How does its category compare?

All LJT devices

LJT Port & Catheter, Implanted, Subcutaneous, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LJT

2in 2025

2007: 112008: 72009: 22010: 22011: 52012: 22013: 72014: 22015: 42016: 32019: 12020: 12023: 12024: 12025: 22026 (partial year): 1
2007high 11 (2007) · low 0 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LJT

182in 2016

2007: 85 days median2008: 119 days median2011: 144 days median2013: 150 days median2015: 164 days median2016: 182 days median
2007high 182 (2016) · low 85 (2007)2026

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

Recalls per year · LJT

1in 2022

2007: 12008: 22009: 22010: 192011: 12012: 22015: 12017: 12018: 12019: 72022: 12026 (partial year): 1, 1 Class I
2007high 19 (2010) · low 0 (2013)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · LJT

4,308in 2025

2007: 2082008: 1612009: 1722010: 2072011: 2022012: 1532013: 1412014: 1432015: 1492016: 1352017: 2622018: 8782019: 7652020: 9592021: 1,2852022: 1,3342023: 1,2212024: 1,8962025: 4,308
2007high 4,308 (2025) · low 135 (2016)2025

MAUDE reports naming product code LJT, 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
200711851208
200871192161
20092—2172
20102—19207
201151441202
20122—2153
201371500141
20142—0143
201541641149
201631820135
20170—1262
20180—1878
20191—7765
20201—0959
20210—01,285
20220—11,334
20231—01,221
20241—01,896
20252—04,308
20261—1 (1)—
Cite this page

510(k) Report. “K912702: Plastic Attachable Dual Port.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K912702

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