510(k) Report

510(k) · Cleared

Cleared

Model 6100 Ambulatory Infusion System

K943310510(k) TraditionalCleared Feb 21, 1995225-day reviewClass II21 CFR 880.5725

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

Pharmacia Deltec, Inc. · MEA Pump, Infusion, Pca

Cleared on Feb 21, 1995 after a 225-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided
Feb 21, 1995
Review
225 days
Class
Class II
Product code
MEA
Recalls
None
Predicates
0

2 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 1999: 2 descendants cleared1995200020052010201520202025
  1. This deviceK943310 Model 6100 Ambulatory Infusion SystemPharmacia Deltec, Inc. · 1995
  2. Descendant · cites it directly · 0 of its ownK991599 Cadd Administration SetSims Deltec, Inc. · 1999 · Recalled
  3. Descendant · cites it directly · 0 of its ownK991301 Cadd-Prizm High Volume Administration Set with 1.2 U Filter and…Sims Deltec, Inc. · 1999 · Recalled

Most influential descendants

Showing 2 of 2 · See all
  • K991599Cadd Administration SetSims Deltec, Inc. · 1999 · cites it directly0descendants
  • K991301Cadd-Prizm High Volume Administration Set with 1.2 U Filter and Add-on Anti-Siphon…Sims Deltec, Inc. · 1999 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K943310Model 6100 Ambulatory Infusion SystemPharmacia Deltec, Inc.1995—
+1K991599Cadd Administration SetSims Deltec, Inc.199932
+1K991301Cadd-Prizm High Volume Administration Set with 1.2 U Filter and Add-on…Sims Deltec, Inc.19991

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199920
FIG. 1 — Lineage of K943310, 1995–1999Source: 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 MEA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K991599Cadd Administration SetSims Deltec, Inc.19990
K991301Cadd-Prizm High Volume Administration Set with 1.2 U Filter and Add-on Anti-Siphon…Sims Deltec, Inc.19990

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, K991599 (Sims Deltec, Inc., 1999) has gone furthest, with 0 descendants of its own.

How does its category compare?

All MEA devices

MEA Pump, Infusion, Pca: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MEA

2in 2017

2008: 12009: 12013: 12016: 12017: 2
2007high 2 (2017) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MEA

Too few MEA 510(k)s in any year since 2007 to give a median.

Recalls per year · MEA

1in 2024

2008: 12010: 42011: 22014: 12017: 22022: 12024: 1
2007high 4 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MEA

3,278in 2025

2007: 812008: 2372009: 1532010: 2192011: 2452012: 4462013: 4532014: 3822015: 992016: 572017: 442018: 2562019: 1322020: 2,3312021: 3,7762022: 6,4432023: 3,9842024: 4,5592025: 3,278
2007high 6,443 (2022) · low 44 (2017)2025

MAUDE reports naming product code MEA, 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
20070—081
20081—1237
20091—0153
20100—4219
20110—2245
20120—0446
20131—0453
20140—1382
20150—099
20161—057
20172—244
20180—0256
20190—0132
20200—02,331
20210—03,776
20220—16,443
20230—03,984
20240—14,559
20250—03,278
20260—0—

More from Pharmacia Deltec, Inc.

43 FDA decisions under this applicant name. See the company

  • K942046Pharmacia Deltec Extension Set with Anti-Siphon ValvePharmacia Deltec, Inc. · 1994
  • K942161LockboxPharmacia Deltec, Inc. · 1994
  • K942024Port-a-Cath Low Profile Implantable Venous Access SystemPharmacia Deltec, Inc. · 19948 recalls
  • K941445Extension Set with Anti-Siphon ValvePharmacia Deltec, Inc. · 1994
  • K931073Cath-FinderPharmacia Deltec, Inc. · 19944 recalls

Recent decisions in MEA

The MEA category page

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  • K143612LifeCare PCA Infusion SystemHospira, Inc. · 2016
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https://510kreport.com/device/K943310 · printed Nov 6, 2026

Cite this page

510(k) Report. “K943310: Model 6100 Ambulatory Infusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K943310

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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