510(k) Report

510(k) · Cleared

Recalled · 2002

1ST Response Manual Resuscitator, Model 85XX

K014115510(k) TraditionalCleared Feb 27, 200275-day reviewClass II21 CFR 868.5915Recalls 3

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

Portex, Inc. · BTM Ventilator, Emergency, Manual (Resuscitator)

Cleared on Feb 27, 2002 as substantially equivalent to K992057 (Sims Portex, Inc., 1999) after a 75-day review. Its family tree reaches back 1 generation to 1999. It has been recalled 3 times.

Decided
Feb 27, 2002
Review
75 days
Class
Class II
Product code
BTM
Recalls
3
Predicates
1

Its longest line of descent runs back 1 generation to K992057 (1999). No later device cites it as a predicate yet.

K992057 · Ist Response Manual Resuscitator, Models, 008000, 008003,008006 · Sims Portex, Inc. · 199919961998200020022004
K992057 · Ist Response Manual Resuscitator, Models, 008000, 008003,008006 · Sims Portex, Inc. · 19990
  1. Root · 1 generation backK992057 Ist Response Manual Resuscitator, Models, 008000, 008003,008006Sims Portex, Inc. · 1999
  2. This deviceK014115 1ST Response Manual Resuscitator, Model 85XXPortex, Inc. · 2002
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K992057Ist Response Manual Resuscitator, Models, 008000, 008003,008006Sims Portex, Inc.1999—
0 (this device)K0141151ST Response Manual Resuscitator, Model 85XXPortex, Inc.2002—
FIG. 1 — Lineage of K014115, 1999–2002Source: 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 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
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What was it cleared against? (1)

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
*K992057Ist Response Manual Resuscitator, Models, 008000, 008003,008006
Summary page 1
…ATION: Class II, 73 BTM, 21 CFR 868.5915 PREDICATE DEVICE(S): Portex, Inc., Ft. Myers Florida, 1* Response Manual Resuscitators, Cat. No. 008000, 008003, and 008006, (K992057). smtths | 2 Smiths Medical - a part of Smiths Group plc DESCRIPTION: The 1* Response manual resuscitator is a…
Sims Portex, Inc.1999—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Nov 15, 2002Not classifiedZ-0808-03OtherPeep valve set at the highest level and could result in patient injury
Nov 15, 2002Not classifiedZ-0809-03OtherPeep valve set at the highest level and could result in patient injury
Nov 15, 2002Not classifiedZ-0810-03OtherPeep valve set at the highest level and could result in patient injury

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.

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?

The 1* Response Manual Resuscitator is a pulmonary-assist device intended to provide respiratory support to patients suffering from respiratory distress. It is intended for use on patients with a body mass of 25 kg (55 Ibs) or more.

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

More from Portex, Inc.

20 FDA decisions under this applicant name. See the company

  • K033080Portex 24G Pediatric Epidural and Peripheral Block Anesthesia CatheterPortex, Inc. · 2004
  • K031057Per-Fit Percutaneous Dilational Tracheostomy KitPortex, Inc. · 20037 recalls
  • K0237931ST Response Intermediate Manual ResuscitatorPortex, Inc. · 2003
  • K014073Hypodermic Needle-Pro Insulin Syrine & Needle with Needle Protection DevicePortex, Inc. · 2002
  • K873992Laryngectomy TubePortex, Inc. · 1988

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/K014115 · printed Nov 6, 2026

Cite this page

510(k) Report. “K014115: 1ST Response Manual Resuscitator, Model 85XX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K014115

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026