510(k) Report

510(k) · Cleared

Cleared

Modification to Engineered Medical Systems Disposable Manual Resuscitator with CO2 Detection

K991955510(k) TraditionalCleared Jul 6, 199935-day reviewClass II21 CFR 868.5915

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

Engineered Medical Systems · BTM Ventilator, Emergency, Manual (Resuscitator)

Cleared on Jul 6, 1999 as substantially equivalent to K912203 (Engineered Medical Systems, 1991) and 4 other predicates after a 35-day review. Its family tree reaches back 3 generations to 1989.

Decided
Jul 6, 1999
Review
35 days
Class
Class II
Product code
BTM
Recalls
None
Predicates
5

Its longest line of descent runs back 3 generations to K894053 (1989). 8 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1994: 2 other ancestors1993: 2 other ancestors1991: 1 other ancestorK894053 · 2ND Modification of Fef (TM) End-Tidal CO2 Detector · Fenem, Inc. · 1989K960468 · DMR/CO2 Combo Kti · Nellcor Puritan Bennett, Inc. · 1996K973419 · DMR Plus Disposable Manual Resuscitator · Nellcor Puritan Bennett, Inc. · 19981985199019952000
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 1 other ancestor3 generations back: 1 other ancestor K973419 · DMR Plus Disposable Manual Resuscitator · Nellcor Puritan Bennett, Inc. · 1998K960468 · DMR/CO2 Combo Kti · Nellcor Puritan Bennett, Inc. · 1996K894053 · 2ND Modification of Fef (TM) End-Tidal CO2 Detector · Fenem, Inc. · 19890
  1. Root · 3 generations backK894053 2ND Modification of Fef (TM) End-Tidal CO2 DetectorFenem, Inc. · 1989
  2. 2 generations backK960468 DMR/CO2 Combo KtiNellcor Puritan Bennett, Inc. · 1996
  3. 1 generation backK973419 DMR Plus Disposable Manual ResuscitatorNellcor Puritan Bennett, Inc. · 1998
  4. This deviceK991955 Modification to Engineered Medical Systems Disposable Manual…Engineered Medical Systems · 1999
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K8940532ND Modification of Fef (TM) End-Tidal CO2 DetectorFenem, Inc.1989—
−2K960468DMR/CO2 Combo KtiNellcor Puritan Bennett, Inc.1996—
−1K973419DMR Plus Disposable Manual ResuscitatorNellcor Puritan Bennett, Inc.1998—
0 (this device)K991955Modification to Engineered Medical Systems Disposable Manual Resuscitator with…Engineered Medical Systems1999—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
199320
199420
FIG. 1 — Lineage of K991955, 1989–1999Source: 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), 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 BTM? 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 BTM device

  1. #1 K243861 butterflyBVMscore 9.5 · 2 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? (5)

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
*K912203Ems Single Use Manual Resuscitators
Summary page 1
…Manual Ventilator Resuscitator Device: EMS Disposable Manual Resuscitator with CO, Detection Predicate Devices: EMS Disposable Manual Resuscitator with CO, Detection - K912203B and K924610A Nellcor Puritan Bennett - DMR2 Plus Manual Resuscitator with CO, Detection - K973419 Nellcor Puritan Bennett - Ea…
Engineered Medical Systems1991—
*K924610Baxter Adult/Pedi/Infant Single Use Man Resuscit
Summary page 1
…ator Resuscitator Device: EMS Disposable Manual Resuscitator with CO, Detection Predicate Devices: EMS Disposable Manual Resuscitator with CO, Detection - K912203B and K924610A Nellcor Puritan Bennett - DMR2 Plus Manual Resuscitator with CO, Detection - K973419 Nellcor Puritan Bennett - EasyCap CO, Det…
Engineered Medical Systems19931
*K973419DMR Plus Disposable Manual Resuscitator
Summary page 1
…cate Devices: EMS Disposable Manual Resuscitator with CO, Detection - K912203B and K924610A Nellcor Puritan Bennett - DMR2 Plus Manual Resuscitator with CO, Detection - K973419 Nellcor Puritan Bennett - EasyCap CO, Detector - K894053 and K944400 |Deyic’e*l)‘éscriptiifi’ii . e — _-:] The EMS Disposable…
Nellcor Puritan Bennett, Inc.1998—
*K8940532ND Modification of Fef (TM) End-Tidal CO2 Detector
Summary page 1
…Detection - K912203B and K924610A Nellcor Puritan Bennett - DMR2 Plus Manual Resuscitator with CO, Detection - K973419 Nellcor Puritan Bennett - EasyCap CO, Detector - K894053 and K944400 |Deyic’e*l)‘éscriptiifi’ii . e — _-:] The EMS Disposable Manual Resuscitator is a bag-valve-mask device with the ca…
Fenem, Inc.1989—
*K944400Pedi-Cap
Summary page 1
…K912203B and K924610A Nellcor Puritan Bennett - DMR2 Plus Manual Resuscitator with CO, Detection - K973419 Nellcor Puritan Bennett - EasyCap CO, Detector - K894053 and K944400 |Deyic’e*l)‘éscriptiifi’ii . e — _-:] The EMS Disposable Manual Resuscitator is a bag-valve-mask device with the capability of…
Nellcor, Inc.19941

Also cleared against K912203: 1 other device →

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 10 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
  • 2 of the 8 ancestors have a recall of any class.
  • 1 other device also cites its predicate K912203.

How does its category compare?

All BTM devices

BTM Ventilator, Emergency, Manual (Resuscitator): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · BTM

2in 2025

2007: 22008: 32010: 22011: 22012: 12015: 12016: 12018: 22021: 12022: 12023: 12025: 22026 (partial year): 1
2007high 3 (2008) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · BTM

83in 2008

2008: 83 days median
2007high 83 (2008)2026

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

Recalls per year · BTM

9in 2024

2009: 232010: 32012: 13, 13 Class I2013: 3, 1 Class I2023: 92024: 9, 9 Class I2026 (partial year): 1, 1 Class I
2007high 23 (2009) · low 0 (2007)2026

Class I (24 since 2007) Class II/III not classified

Adverse event reports per year · BTM

36in 2025

2007: 652008: 312009: 212010: 232011: 482012: 692013: 442014: 1082015: 362016: 922017: 562018: 562019: 462020: 262021: 422022: 352023: 462024: 332025: 36
2007high 108 (2014) · low 21 (2009)2025

MAUDE reports naming product code BTM, 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—065
2008383031
20090—2321
20102—323
20112—048
20121—13 (13)69
20130—3 (1)44
20140—0108
20151—036
20161—092
20170—056
20182—056
20190—046
20200—026
20211—042
20221—035
20231—946
20240—9 (9)33
20252—036
20261—1 (1)—

What is it indicated for?

Disposable manual resuscitator with CO₂ detection for use with patients requiring manual ventilatory support. The CO₂ detector is located on the expiratory port. It may be supplied separately and attached to any resuscitator expiratory port. The CO₂ detector assists in verification of the endotracheal tube placing during endotracheal or nasotracheal intubation. The CO₂ detector detects approximate ranges of CO₂ by color comparison. It is intended for use by qualified healthcare professionals in any environment where pulmonary support resuscitation is indicated such as in the hospital, transport, mobile or home settings.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K912203

1 other device cites the same predicate.

  • K991953Modification to Engineered Medical Systems Disposable Manual Resuscitator with CO2 DetectionEngineered Medical Systems · 1999

More from Engineered Medical Systems

22 FDA decisions under this applicant name. See the company

  • K023683Multi-Strap Full Face MaskEngineered Medical Systems · 2003
  • K013728Trach VoxEngineered Medical Systems · 2002
  • K013122Ems Electrostatic Fliter and Hme CombinationEngineered Medical Systems · 2002
  • K013089Ems Hepa Filter and Hme CombinationsEngineered Medical Systems · 2002
  • K013123Ems Pulmonary Function Testing FilterEngineered Medical Systems · 2002

Recent decisions in BTM

The BTM category page

  • K263254Disposable Manual Resuscitator (NPVC-001/RTMA;NPVC-002/RTMA;NPVC-003/RTMA1)Xiamen Compower Medical Tech. Co., Ltd. · 2026
  • K251631The BAG manual resuscitator and accessoriesLaerdal Medical AS · 2025
  • K243861butterflyBVMCompact Medical, Inc. · 2025
  • K221841EOlife®Archeon · 2023
  • K212905Sotair DeviceSafe Bvm Corporation · 2022

https://510kreport.com/device/K991955 · printed Nov 5, 2026

Cite this page

510(k) Report. “K991955: Modification to Engineered Medical Systems Disposable Manual Resuscitator with CO2 Detection.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K991955

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
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026