510(k) Report

510(k) · Cleared

Cleared

.22 & 1.2 Micron IV Filters

K894954510(k) TraditionalCleared Nov 13, 1989101-day reviewClass II21 CFR 880.5440

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

Churchill Medical Systems, Inc. · FPB Filter, Infusion Line

Cleared on Nov 13, 1989 after a 101-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Nov 13, 1989
Review
101 days
Class
Class II
Product code
FPB
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2010: 1 descendant cleared1990200020102020
  1. This deviceK894954 .22 & 1.2 Micron IV FiltersChurchill Medical Systems, Inc. · 1989
  2. Descendant · cites it directly · 0 of its ownK093271 Extension Set (Standardbore Tubing), Extension Set (Minibore…Victus, Inc. · 2010

Most influential descendants

Showing 1 of 1 · See all
  • K093271Extension Set (Standardbore Tubing), Extension Set (Minibore Tubing), IV Administration…Victus, Inc. · 2010 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K894954.22 & 1.2 Micron IV FiltersChurchill Medical Systems, Inc.1989—
+1K093271Extension Set (Standardbore Tubing), Extension Set (Minibore Tubing), IV…Victus, Inc.2010—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
FIG. 1 — Lineage of K894954, 1989–2010Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 FPB? 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 FPB device

  1. #1 K261403 Lipipor NLF1A Infusion Filter, Lipipor NLF2A &…score 11.9 · 1 generation · no Class I recall
  2. #2 Held for the reportin the report
Get a 510(k) Report

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? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K093271Extension Set (Standardbore Tubing), Extension Set (Minibore Tubing), IV Administration…Victus, Inc.20100

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, K093271 (Victus, Inc., 2010) has gone furthest, with 0 descendants of its own.

How does its category compare?

All FPB devices

FPB Filter, Infusion Line: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FPB

1in 2024

2011: 12015: 12024: 12026 (partial year): 1
2007high 1 (2011) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FPB

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

Recalls per year · FPB

1in 2011

2011: 1
2007high 1 (2011) · low 0 (2007)2026

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

Adverse event reports per year · FPB

33in 2025

2007: 142008: 442009: 332010: 322011: 202012: 212013: 442014: 672015: 252016: 952017: 532018: 352019: 312020: 182021: 1602022: 362023: 392024: 472025: 33
2007high 160 (2021) · low 14 (2007)2025

MAUDE reports naming product code FPB, 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—014
20080—044
20090—033
20100—032
20111—120
20120—021
20130—044
20140—067
20151—025
20160—095
20170—053
20180—035
20190—031
20200—018
20210—0160
20220—036
20230—039
20241—047
20250—033
20261—0—

More from Churchill Medical Systems, Inc.

12 FDA decisions under this applicant name. See the company

  • K041038Churchill Medical Dual Chamber Empty ContainerChurchill Medical Systems, Inc. · 2004
  • K021395Modification to 30 Extension SetChurchill Medical Systems, Inc. · 200218 recalls
  • K013949Universal Vial Access Spike with Needleless ConnectorChurchill Medical Systems, Inc. · 2002
  • K020544Wing Safe Infusion Set 20 GA, SHS2000 Series; Wing Safe Infusion Set 19 GA, SHS1900 Series; Wing Safe…Churchill Medical Systems, Inc. · 20021 recall
  • K013950Vented Vial Access DeviceChurchill Medical Systems, Inc. · 2002

Recent decisions in FPB

The FPB category page

  • K261403Lipipor NLF1A Infusion Filter, Lipipor NLF2A & NLF2NTA Infusion Filters, Lipipor TNA2A Infusion FilterGlobal Life Sciences Solutions USA, LLC · 2026
  • K233277Filter Needle for Single UseHangzhou Qiantang Longyue Biotechnology Co., Ltd. · 2024
  • K143583Cathivex ¿GV filter unitsMerck Millipore, Ltd. · 2015
  • K113227Non-Dehp Micro-Volume Extension Set with 0.22 Micron FilterBaxter Healthcare Corp · 2011
  • K021293Arteria Blood FilterArteria Medical Science, Inc. · 2002

https://510kreport.com/device/K894954 · printed Nov 5, 2026

Cite this page

510(k) Report. “K894954: .22 & 1.2 Micron IV Filters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K894954

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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