510(k) Report

510(k) · Cleared

Cleared

Revised Pneumatic Diagrams for Modulus II Plus

K882489510(k) TraditionalCleared Jul 8, 198822-day reviewClass II21 CFR 868.5160

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

Ohmeda Medical · BSZ Gas-Machine, Anesthesia

Cleared on Jul 8, 1988 after a 22-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
Jul 8, 1988
Review
22 days
Class
Class II
Product code
BSZ
Recalls
None
Predicates
0

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

Descendants, by year cleared 1997: 1 descendant cleared1990200020102020
  1. This deviceK882489 Revised Pneumatic Diagrams for Modulus II PlusOhmeda Medical · 1988
  2. Descendant · cites it directly · 0 of its ownK963481 Anodyne CCHeyer America, Inc. · 1997

Most influential descendants

Showing 1 of 1 · See all
  • K963481Anodyne CCHeyer America, Inc. · 1997 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K882489Revised Pneumatic Diagrams for Modulus II PlusOhmeda Medical1988—
+1K963481Anodyne CCHeyer America, Inc.1997—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
FIG. 1 — Lineage of K882489, 1988–1997Source: 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 BSZ? 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 BSZ device

  1. #1 K253330 A5 Anesthesia System (A5); A7 Anesthesia…score 16.7 · 18 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?

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
K963481Anodyne CCHeyer America, Inc.19970

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, K963481 (Heyer America, Inc., 1997) has gone furthest, with 0 descendants of its own.

How does its category compare?

All BSZ devices

BSZ Gas-Machine, Anesthesia: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · BSZ

1in 2025

2007: 32008: 82009: 32010: 12011: 62012: 52013: 52014: 42015: 42016: 12017: 32018: 22020: 12021: 12023: 22025: 12026 (partial year): 2
2007high 8 (2008) · low 0 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · BSZ

145in 2017

2007: 175 days median2008: 99 days median2009: 34 days median2011: 218 days median2012: 134 days median2013: 125 days median2014: 235 days median2015: 134 days median2017: 145 days median
2007high 235 (2014) · low 34 (2009)2026

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

Recalls per year · BSZ

5in 2025

2007: 12008: 82009: 32010: 142011: 12012: 7, 6 Class I2013: 5, 5 Class I2015: 7, 2 Class I2016: 12017: 5, 1 Class I2018: 32019: 5, 2 Class I2020: 72021: 2, 1 Class I2022: 4, 3 Class I2023: 62024: 13, 13 Class I2025: 5, 3 Class I2026 (partial year): 7, 2 Class I
2007high 14 (2010) · low 0 (2014)2026

Class I (38 since 2007) Class II/III not classified

Adverse event reports per year · BSZ

9,198in 2025

2007: 1322008: 1042009: 852010: 972011: 872012: 892013: 3082014: 2792015: 5722016: 2,1352017: 2,3552018: 2,5892019: 1,9572020: 2,6872021: 3,1232022: 4,3522023: 5,5952024: 6,0672025: 9,198
2007high 9,198 (2025) · low 85 (2009)2025

MAUDE reports naming product code BSZ, 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
200731751132
20088998104
2009334385
20101—1497
20116218187
201251347 (6)89
201351255 (5)308
201442350279
201541347 (2)572
20161—12,135
201731455 (1)2,355
20182—32,589
20190—5 (2)1,957
20201—72,687
20211—2 (1)3,123
20220—4 (3)4,352
20232—65,595
20240—13 (13)6,067
20251—5 (3)9,198
20262—7 (2)—

More from Ohmeda Medical

120 FDA decisions under this applicant name. See the company

  • K123309Giraffe and Panda WarmersOhmeda Medical · 20133 Class I recalls
  • K101788Giraffe OmnibedOhmeda Medical · 20103 Class I recalls
  • K101778Giraffe IncubatorOhmeda Medical · 20101 Class I recall
  • K090697Modification to: Giraffe and Panda WarmerOhmeda Medical · 20091 Class I recall
  • K072157Modification to Giraffe and Panda Warmers (Giraffe and Panda Uninterruptible Power Supply)Ohmeda Medical · 20071 recall

Recent decisions in BSZ

The BSZ category page

  • K253330A5 Anesthesia System (A5); A7 Anesthesia System (A7)Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2026
  • K252746Atlan (A100); Atlan (A100 XL); Atlan (A350); Atlan (A350 XL)Drägerwerk AG Co. Kgaa · 2026
  • K251352Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and related 610i, 620i, 630i series…Codonics.Incorporated · 2025
  • K230931AtlanDrägerwerk AG Co. Kgaa · 20238 Class I recalls
  • K213867Carestation 750/750cDatex-Ohmeda, Inc. · 20234 Class I recalls

https://510kreport.com/device/K882489 · printed Nov 5, 2026

Cite this page

510(k) Report. “K882489: Revised Pneumatic Diagrams for Modulus II Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K882489

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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