510(k) Report

510(k) · Cleared

Cleared

Biochem 9100 Multigas Monitor Ibp Module

K921388510(k) TraditionalCleared May 26, 1993429-day reviewClass II21 CFR 870.1110

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

Biochem International, Inc. · DSK Computer, Blood-Pressure

Cleared on May 26, 1993 after a 429-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 129 later devices descend from it.

Decided
May 26, 1993
Review
429 days
Class
Class II
Product code
DSK
Recalls
None
Predicates
0

129 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1996: 1 descendant cleared2003: 2 descendants cleared1997: 1 descendant cleared2004: 6 descendants cleared2005: 5 descendants cleared2006: 11 descendants cleared2010: 11 descendants cleared1999: 3 descendants cleared2008: 7 descendants cleared2007: 5 descendants cleared2009: 15 descendants cleared2013: 13 descendants cleared2012: 6 descendants cleared2002: 1 descendant cleared2011: 11 descendants cleared2014: 6 descendants cleared2018: 3 descendants cleared2020: 3 descendants cleared2017: 5 descendants cleared2015: 2 descendants cleared2022: 3 descendants cleared2025: 5 descendants cleared2016: 1 descendant cleared2023: 1 descendant cleared2026: 1 descendant cleared2024: 1 descendant cleared1990200020102020
  1. This deviceK921388 Biochem 9100 Multigas Monitor Ibp ModuleBiochem International, Inc. · 1993
  2. Descendant · cites it directly · 128 of its ownK952979 Hanc NetworkHealthtech Services Corp. · 1996
  3. Descendant · 2 generations on · 123 of its ownK964408 Poseidon Cardiac Monitoring System (PCMS)Instromedix, Inc. · 1997
  4. Descendant · 3 generations on · 103 of its ownK993169 Modification of: Physiological Signal Transmitter and Receiver…Hewlett-Packard Co. · 1999
  5. Descendant · 4 generations on · 98 of its ownK023749 The M3810A Philips Telemonitoring System with M3812B Telestation…Philips Medical Systems · 2002
  6. Descendant · 4 generations on · 90 of its ownK031840 Carematix Wellness SystemCarematix, Inc. · 2003

Showing 5 of 129 descendants. See all descendants

Descendants cleared per year

1996: 11997: 11999: 32002: 12003: 22004: 62005: 52006: 112007: 52008: 72009: 152010: 112011: 112012: 62013: 132014: 62015: 22016: 12017: 52018: 32020: 32022: 32023: 12024: 12025: 52026: 1
1996high 15 (2009) · low 0 (1998)2026

Most influential descendants

Showing 5 of 129 · See all
  • K952979Hanc NetworkHealthtech Services Corp. · 1996 · cites it directly128descendants
  • K964408Poseidon Cardiac Monitoring System (PCMS)Instromedix, Inc. · 1997 · 2 generations on123descendants
  • K993169Modification of: Physiological Signal Transmitter and Receiver, Model 3810AHewlett-Packard Co. · 1999 · 3 generations on103descendants
  • K023749The M3810A Philips Telemonitoring System with M3812B Telestation (M310A/12B)Philips Medical Systems · 2002 · 4 generations on98descendants
  • K031840Carematix Wellness SystemCarematix, Inc. · 2003 · 4 generations on90descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K921388Biochem 9100 Multigas Monitor Ibp ModuleBiochem International, Inc.1993—
+1K952979Hanc NetworkHealthtech Services Corp.1996—
+2K964408Poseidon Cardiac Monitoring System (PCMS)Instromedix, Inc.1997—
+3K993169Modification of: Physiological Signal Transmitter and Receiver, Model 3810AHewlett-Packard Co.1999—
+4K023749The M3810A Philips Telemonitoring System with M3812B Telestation (M310A/12B)Philips Medical Systems2002—
+4K031840Carematix Wellness SystemCarematix, Inc.2003—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
199710
199930
200210
200320
200460
200550
2006110
200750
200870
2009150
2010110
2011110
201260
2013130
201460
201520
201610
201750
201830
202030
202230
202310
202410
202550
202610
FIG. 1 — Lineage of K921388, 1993–2026Source: 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 DSK? 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 DSK device

  1. #1 K231586 Endophys Blood Pressure Monitor model BPM-30score 8.7 · 9 generations · no Class I recall
Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (129)

See all 129

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

NumberDeviceApplicantDecidedDescendants
K952979Hanc NetworkHealthtech Services Corp.1996128

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, K952979 (Healthtech Services Corp., 1996) has gone furthest, with 128 descendants of its own.

How does its category compare?

All DSK devices

DSK Computer, Blood-Pressure: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DSK

1in 2023

2007: 12008: 12015: 22016: 12023: 1
2007high 2 (2015) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DSK

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

Recalls per year · DSK

No recall names DSK since 2007.

Adverse event reports per year · DSK

26in 2025

2010: 102011: 52012: 692013: 52014: 82015: 72016: 132017: 62018: 932019: 1482020: 292021: 312022: 292023: 142024: 122025: 26
2007high 148 (2019) · low 0 (2007)2025

MAUDE reports naming product code DSK, 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
20071—00
20081—00
20090—00
20100—010
20110—05
20120—069
20130—05
20140—08
20152—07
20161—013
20170—06
20180—093
20190—0148
20200—029
20210—031
20220—029
20231—014
20240—012
20250—026
20260—0—

More from Biochem International, Inc.

33 FDA decisions under this applicant name. See the company

  • K920083Biochem Model 3302 NEWOX2 OximeterBiochem International, Inc. · 1994
  • K9323898100 Anesthetic Agent MonitorBiochem International, Inc. · 1993
  • K920082Biochem Model 3301 NEWOX1 OximeterBiochem International, Inc. · 1993
  • K910381Biochem Temperature/ FIO2 ModuleBiochem International, Inc. · 1991
  • K911351Biochem 9100 Multigas Monitor Temp/FIO1 Mod,NibpBiochem International, Inc. · 1991

Recent decisions in DSK

The DSK category page

  • K231586Endophys Blood Pressure Monitor model BPM-30Endophys Technologies, LLC · 2023
  • K160945Endophys Blood Pressure MonitorEndophys Holdings, LLC · 2016
  • K152582CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter BoxVolcano Corporation · 2015
  • K141615Endophys Blood Pressure MonitorEndophys, Inc. · 2015
  • K080670Modification to Sphygmocor Cardiovascular Management SystemAtcor Medical · 2008

https://510kreport.com/device/K921388 · printed Nov 6, 2026

Cite this page

510(k) Report. “K921388: Biochem 9100 Multigas Monitor Ibp Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K921388

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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