510(k) Report

510(k) · Cleared

Recalled · 2006

Modular

K001988510(k) TraditionalCleared Feb 5, 2001221-day reviewClass II21 CFR 868.5160Recalls 1

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

Heyer America, Inc. · BSZ Gas-Machine, Anesthesia

Cleared on Feb 5, 2001 after a 221-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 13 devices in its family, counting itself, has a Class I recall. 12 later devices descend from it. It has been recalled once.

Decided
Feb 5, 2001
Review
221 days
Class
Class II
Product code
BSZ
Recalls
1
Predicates
0

12 later devices descend from it, 1 citing it directly. 1 of the 13 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2008: 1 descendant cleared2011: 1 descendant cleared, 1 with a Class I recall12012: 1 descendant cleared2013: 1 descendant cleared2015: 2 descendants cleared2018: 2 descendants cleared2014: 1 descendant cleared2021: 1 descendant cleared2019: 1 descendant cleared2026: 1 descendant cleared200020052010201520202025
  1. This deviceK001988 ModularHeyer America, Inc. · 2001
  2. Descendant · cites it directly · 11 of its ownK080175 Navigator Anesthesia Delivery System, Model 0998-00-3024-01Datascope Corp., Patient Monitoring Division · 2008 · Recalled
  3. Descendant · 2 generations on · 9 of its ownK102471 AS3700 Anesthsia Delivery SystemMindray DS USA, Inc. · 2011 · Recalled (Class I)
  4. Descendant · 3 generations on · 8 of its ownK123211 A5 Anesthesia Delivery SystemDatascope Corp., Patient Monitoring Division · 2013 · Recalled
  5. Descendant · 4 generations on · 5 of its ownK142552 A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015
  6. Descendant · 5 generations on · 4 of its ownK151954 A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015 · Recalled

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2008: 12011: 12012: 12013: 12014: 12015: 22018: 22019: 12021: 12026: 1
2008high 2 (2015) · low 0 (2009)2026

Class I recalls in this family

  • K102471 AS3700 Anesthsia Delivery System2 generations on · 2011

Most influential descendants

Showing 5 of 12 · See all
  • K080175Navigator Anesthesia Delivery System, Model 0998-00-3024-01Datascope Corp., Patient Monitoring Division · 2008 · cites it directly11descendants
  • K102471AS3700 Anesthsia Delivery SystemMindray DS USA, Inc. · 2011 · 2 generations on9descendants
  • K123211A5 Anesthesia Delivery SystemDatascope Corp., Patient Monitoring Division · 2013 · 3 generations on8descendants
  • K142552A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015 · 4 generations on5descendants
  • K151954A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015 · 5 generations on4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K001988ModularHeyer America, Inc.2001—
+1K080175Navigator Anesthesia Delivery System, Model 0998-00-3024-01Datascope Corp., Patient Monitoring Division20082
+2K102471AS3700 Anesthsia Delivery SystemMindray DS USA, Inc.2011Class I
+3K123211A5 Anesthesia Delivery SystemDatascope Corp., Patient Monitoring Division20131
+4K142552A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2015—
+5K151954A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20153

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
201111
201210
201310
201410
201520
201820
201910
202110
202610
FIG. 1 — Lineage of K001988, 2001–2026Source: 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.

1 device in this family has a Class I recall. 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
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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? (12)

See all 12

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

NumberDeviceApplicantDecidedDescendants
K080175Navigator Anesthesia Delivery System, Model 0998-00-3024-01Datascope Corp., Patient Monitoring Division200811

Has anything in its family been recalled? (1 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Mar 17, 2006Not classifiedZ-0929-06OtherThe Anestar and Anestar Plus Anesthesia System may produce periods of high Positive End-Expiratory Pressure (PEEP), in both manual and mechanical ventilation mode due to an issue with the Applied Pressure Limit (APL) valve.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K102471AS3700 Anesthsia Delivery SystemMindray DS USA, Inc. · 2011 · 2 generations on · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls

What does this lineage say?

  • Of its descendants, K080175 (Datascope Corp., Patient Monitoring Division, 2008) has gone furthest, with 11 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 Heyer America, Inc.

4 FDA decisions under this applicant name. See the company

  • K000995Narkomat, Model 2000Heyer America, Inc. · 2000
  • K963481Anodyne CCHeyer America, Inc. · 1997
  • K912566Minitrop Aerosol UnitHeyer America, Inc. · 1991

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/K001988 · printed Nov 6, 2026

Cite this page

510(k) Report. “K001988: Modular.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001988

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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