510(k) · Cleared

Recalled · 2006

P.a.S. Port Elite Implantable Venous Access System

K992880510(k) TraditionalCleared Oct 19, 199953-day reviewClass II21 CFR 880.5965Recalls 2

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

Sims Deltec, Inc. · LJT Port & Catheter, Implanted, Subcutaneous, Intravascular

Cleared on Oct 19, 1999 as substantially equivalent to K875276 (Pharmacia Deltec, Inc., 1988) after a 53-day review. Its family tree reaches back 1 generation to 1988. It has been recalled 2 times.

Decided: Oct 19, 1999
Review: 53 days
Class: Class II
Product code: LJT
Recalls: 2
Predicates: 1

Its longest line of descent runs back 1 generation to K875276 (1988). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK875276 Port-a-Cath (R) Implantable Drug Delivery SystemPharmacia Deltec, Inc. · 1988
This deviceK992880 P.a.S. Port Elite Implantable Venous Access SystemSims Deltec, Inc. · 1999

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K875276	Port-a-Cath (R) Implantable Drug Delivery System	Pharmacia Deltec, Inc.	1988	—
0 (this device)	K992880	P.a.S. Port Elite Implantable Venous Access System	Sims Deltec, Inc.	1999	—

FIG. 1 — Lineage of K992880, 1988–1999Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 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 K251253 PowerPort™ isp Implantable Port; PowerPort™…score 14.9 · 9 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (2)

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	Applicant	Decided	Recalls
*	K875276	Port-a-Cath (R) Implantable Drug Delivery System Summary page 2 …T® Elite P.A.S. PORT® M.R.L® Low Profile Systems Systems Implanted Port MANUFACTURER SIMS Deltec, Inc. SIMS Deltec, Inc. Bard Access Systems 510(K) NUMBER Subject Device K875276 - INDICATION FOR AP.AS. PORT® system \| A system is indicated The M.R.I. Low Profile USE is indicated when patient \| when patient…	Pharmacia Deltec, Inc.	1988	—
*	—	M.R.I.® Low Profile Implanted Port Named without a submission number			—

Also cleared against K875276: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Sep 27, 2006	Not classified	Z-0067-2007	Other	Smiths Medical became aware that product returned to them under recall # Z-0800-06/ Z-0807-06 was inadvertently distributed to consignees after the recall was initiated 03/29/2006. The product was originally recalled because Locator Wand…
Mar 29, 2006	Not classified	Z-0806-06	Other	One lot of Locator-Wand Cover sterile pouches may have an insufficient seal and product sterility could be compromised. The Locator-Wand Cover is supplied with the PORT-A-CATH II AND P.A.S. PORT systems. The packaged Wand-Cover is placed…

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
2 other devices also cite its predicate K875276.

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

2007high 11 (2007) · low 0 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LJT

182in 2016

2007high 182 (2016) · low 85 (2007)2026

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

Recalls per year · LJT

1in 2022

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	11	85	1	208
2008	7	119	2	161
2009	2	—	2	172
2010	2	—	19	207
2011	5	144	1	202
2012	2	—	2	153
2013	7	150	0	141
2014	2	—	0	143
2015	4	164	1	149
2016	3	182	0	135
2017	0	—	1	262
2018	0	—	1	878
2019	1	—	7	765
2020	1	—	0	959
2021	0	—	0	1,285
2022	0	—	1	1,334
2023	1	—	0	1,221
2024	1	—	0	1,896
2025	2	—	0	4,308
2026	1	—	1 (1)	—

What is it indicated for?

A P.A.S. PORT® system is indicated when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling.

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/K992880 · printed Nov 5, 2026

Cite this page

510(k) Report. “K992880: P.a.S. Port Elite Implantable Venous Access System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K992880

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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