510(k) Report

510(k) · Cleared

Cleared

Baxa Pca Infusor

K910257510(k) TraditionalCleared Nov 7, 1991289-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

Baxa Corp., Sub. of Cook Group, Inc. · MEA Pump, Infusion, Pca

Cleared on Nov 7, 1991 after a 289-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Nov 7, 1991
Review
289 days
Class
Class II
Product code
MEA
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K910257Source: FDA 510(k) database · 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.

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  • 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?

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.

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 Baxa Corp., Sub. of Cook Group, Inc.

16 FDA decisions under this applicant name. See the company

  • K903159Valve Controller for Micromacro CompounderBaxa Corp., Sub. of Cook Group, Inc. · 1990
  • K904225KwikmixBaxa Corp., Sub. of Cook Group, Inc. · 1990
  • K900585Tubing Sets for Baxa Exacta-Med Pharmacy PumpBaxa Corp., Sub. of Cook Group, Inc. · 19901 Class I recall
  • K873875Baxa Exacta-Med Pharmacy PumpBaxa Corp., Sub. of Cook Group, Inc. · 1987
  • K872743Baxa Tubing Sets (for Pharmacy Pump)Baxa Corp., Sub. of Cook Group, Inc. · 1987

Recent decisions in MEA

The MEA category page

  • K162165ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent PumpSummit Medical Products, Inc. · 20175 recalls
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  • K143612LifeCare PCA Infusion SystemHospira, Inc. · 2016
  • K130394Cadd -Solis Ambulatory Infusion Pump, Version 3.0Smiths Medical Asd, Inc. · 20131 Class I recall
  • K092313Perfusor Space Infusion Syringe Pump SystemB.Braun Medical, Inc. · 20094 recalls

https://510kreport.com/device/K910257 · printed Nov 4, 2026

Cite this page

510(k) Report. “K910257: Baxa Pca Infusor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K910257

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