510(k) Report

510(k) · Cleared

Cleared

AEROFLEX (TM) Automatic Endoscope Reprocessor with AUTOSURE (TM) MRC Monitor

K181472510(k) TraditionalCleared Apr 23, 2019323-day reviewClass II21 CFR 876.1500

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

Advanced Sterilization Products (Asp) · FEB Accessories, Cleaning, For Endoscope

Cleared on Apr 23, 2019 as substantially equivalent to K103264 (Olympus Medical Systems Corporation, 2011) and 2 other predicates after a 323-day review. Its family tree reaches back 3 generations to 1994.

Decided
Apr 23, 2019
Review
323 days
Class
Class II
Product code
FEB
Recalls
None
Predicates
3

Its longest line of descent runs back 3 generations to K922481 (1994). 6 ancestors in all, the oldest K914145 (1994). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2011: 1 other ancestor2010: 1 other ancestor1994: 1 other ancestorK922481 · Browne GA Indicator Use in 2% Activ Glutaraldehyde · Board of Directors, Albert Browne, Ltd. · 1994 · recalledK991709 · Browne Cidex Opa Indicator · Albert Browne, Ltd. · 1999 · recalledK081427 · Browne Opa Test Strip · STERIS Corporation · 20081990199520002005201020152020
Other ancestors, by generation 1 generation back: 1 other ancestor2 generations back: 1 other ancestor3 generations back: 1 other ancestor K081427 · Browne Opa Test Strip · STERIS Corporation · 2008K991709 · Browne Cidex Opa Indicator · Albert Browne, Ltd. · 1999 · recalledK922481 · Browne GA Indicator Use in 2% Activ Glutaraldehyde · Board of Directors, Albert Browne, Ltd. · 1994 · recalled0
  1. Root · 3 generations backK922481 Browne GA Indicator Use in 2% Activ GlutaraldehydeBoard of Directors, Albert Browne, Ltd. · 1994 · Recalled
  2. 2 generations backK991709 Browne Cidex Opa IndicatorAlbert Browne, Ltd. · 1999 · Recalled
  3. 1 generation backK081427 Browne Opa Test StripSTERIS Corporation · 2008
  4. This deviceK181472 AEROFLEX (TM) Automatic Endoscope Reprocessor with AUTOSURE (TM) MRC…Advanced Sterilization Products (Asp) · 2019
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K922481Browne GA Indicator Use in 2% Activ GlutaraldehydeBoard of Directors, Albert Browne, Ltd.19943
−2K991709Browne Cidex Opa IndicatorAlbert Browne, Ltd.19991
−1K081427Browne Opa Test StripSTERIS Corporation2008—
0 (this device)K181472AEROFLEX (TM) Automatic Endoscope Reprocessor with AUTOSURE (TM) MRC MonitorAdvanced Sterilization Products (Asp)2019—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
201010
201110
FIG. 1 — Lineage of K181472, 1994–2019Source: 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), 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 FEB? 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 FEB device

  1. #1 K243433 enspire 3000 Cleaning and Liquid Chemical…score 10.8 · 9 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (3)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K103264Endoscope Reprocessor Oer-Pro Model Oer-Pro
Summary page 4
…FR Section: 21 CFR 876.1500 Predicate Device The predicate device for the AEROFLEX Automatic Endoscope Reprocessor is the Olympus OER-Pro cleared under 510(k) K103264 (February 23, 2011). The predicate device for the AEROFLEX AER AUTOSURE MRC Monitor is the Browne CIDEX® OPA Test Strips cleared…
Olympus Medical Systems Corporation20116
*K991709Browne Cidex Opa Indicator
Summary page 4
…leared under 510(k) K103264 (February 23, 2011). The predicate device for the AEROFLEX AER AUTOSURE MRC Monitor is the Browne CIDEX® OPA Test Strips cleared under 510(k) K991709 (October 8, 1999) and K081427 (June 11, 2008).…
Albert Browne, Ltd.19991
*K081427Browne Opa Test Strip
Summary page 4
…ebruary 23, 2011). The predicate device for the AEROFLEX AER AUTOSURE MRC Monitor is the Browne CIDEX® OPA Test Strips cleared under 510(k) K991709 (October 8, 1999) and K081427 (June 11, 2008). Page 1 of 8…
STERIS Corporation2008—

Also cleared against K103264: 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)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 25 years and passes through 4 companies; a new generation was cleared every 8.7 years on median.
  • 4 of the 6 ancestors have a recall of any class.
  • 2 other devices also cite its predicate K103264.

How does its category compare?

All FEB devices

FEB Accessories, Cleaning, For Endoscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.

FDA decisions per year · FEB

2in 2024

2007: 22008: 12009: 12010: 22011: 32012: 12013: 12014: 12016: 22017: 22018: 12019: 22020: 22022: 12023: 12024: 22026 (partial year): 1
2007high 3 (2011) · low 0 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FEB

111in 2011

2011: 111 days median
2007high 111 (2011)2026

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

Recalls per year · FEB

15so far in 2026, the most since 2007

2008: 32010: 12016: 22020: 12021: 12023: 12024: 12025: 32026 (partial year): 15
2007high 15 (2026) · low 0 (2007)2026

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

Adverse event reports per year · FEB

356in 2025

2007: 392008: 1522009: 202010: 502011: 322012: 162013: 272014: 482015: 922016: 1032017: 692018: 882019: 622020: 4262021: 5752022: 6072023: 9982024: 8842025: 356
2007high 998 (2023) · low 16 (2012)2025

MAUDE reports naming product code FEB, 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
20072—039
20081—3152
20091—020
20102—150
20113111032
20121—016
20131—027
20141—048
20150—092
20162—2103
20172—069
20181—088
20192—062
20202—1426
20210—1575
20221—0607
20231—1998
20242—1884
20250—3356
20261—15—

What is it indicated for?

The ASP AEROFLEX™ Automatic Endoscope Reprocessor (AER) with AUTOSURE™ MRC Monitor is indicated for use with high-level disinfectant ASP AERO OPA™ ortho-Phthalaldehyde Solution to achieve high-level disinfection of flexible semi-critical endoscopes. Manual cleaning of endoscopes is required prior to placement in the AER.

Indications for use as stated in the FDA summary.

Also cleared against K103264

2 other devices cite the same predicate.

  • K190969ENDOSCOPE REPROCESSOR OER-EliteOlympus Medical Systems Corp. · 20191 recall
  • K120357Endoscope Reprocessor Oer-MiniOlympus Medical Systems Corp. · 20122 recalls

More from Advanced Sterilization Products (Asp)

5 FDA decisions under this applicant name. See the company

  • K192025STERRAD VELOCITY Biological Indicator/Process Challenge Device and ReaderAdvanced Sterilization Products (Asp) · 2020
  • K182404STERRAD VELOCITY Biological IndicatorAdvanced Sterilization Products (Asp) · 2018
  • K170039STERRAD VELOCITY Biological Indictator and ReaderAdvanced Sterilization Products (Asp) · 2017
  • K152189Evotech EcrAdvanced Sterilization Products (Asp) · 20161 recall

Recent decisions in FEB

The FEB category page

  • K261791MEDIVATORS™ ADVANTAGE NXT™ Automated Endoscope ReprocessorSteris · 2026
  • K241168System 83 Revolve Endoscope Washer/DisinfectorWassenburg Medical, Inc. · 2024
  • K243433enspire 3000 Cleaning and Liquid Chemical Sterilant Processing SystemSTERIS Corporation · 2024
  • K230930enspire 3000 Cleaning and Liquid Chemical Sterile Processing SystemSTERIS Corporation · 2023
  • K213833SCOPE BUDDY PLUS Endoscope Flushing AidMedivators, Inc. · 2022

https://510kreport.com/device/K181472 · printed Nov 6, 2026

Cite this page

510(k) Report. “K181472: AEROFLEX (TM) Automatic Endoscope Reprocessor with AUTOSURE (TM) MRC Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181472

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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