510(k) Report

510(k) · Cleared

Cleared

BA-Cpas

K945154510(k) TraditionalCleared Jan 13, 199584-day reviewClass II21 CFR 878.3680

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

Nobelpharma USA, Inc. · FZE Prosthesis, Nose, Internal

Cleared on Jan 13, 1995 after an 84-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 50 later devices descend from it.

Decided
Jan 13, 1995
Review
84 days
Class
Class II
Product code
FZE
Recalls
None
Predicates
0

50 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2009: 3 descendants cleared1999: 3 descendants cleared1996: 1 descendant cleared2016: 6 descendants cleared2002: 1 descendant cleared2004: 1 descendant cleared2008: 3 descendants cleared2011: 5 descendants cleared2005: 1 descendant cleared2017: 1 descendant cleared2015: 4 descendants cleared2024: 1 descendant cleared2010: 1 descendant cleared2012: 1 descendant cleared2013: 4 descendants cleared2021: 5 descendants cleared2019: 1 descendant cleared2018: 2 descendants cleared2026: 4 descendants cleared2025: 2 descendants cleared1995200020052010201520202025
  1. This deviceK945154 BA-CpasNobelpharma USA, Inc. · 1995
  2. Descendant · cites it directly · 45 of its ownK955713 Nobelpharma Bone Anchored Hearing AidNobelpharma USA, Inc. · 1996
  3. Descendant · cites it directly · 43 of its ownK984162 Branemark Bone-Anchored Hearing Aid (Baha) System for Pediatric UseNobelpharma USA, Inc. · 1999
  4. Descendant · 2 generations on · 40 of its ownK021837 Branenmark Bone-Anchored-Hearing Aid (Baha)Entific Medical Systems, Inc. · 2002
  5. Descendant · 2 generations on · 39 of its ownK042017 Baha DivinoEntific Medical Systems, Inc. · 2004
  6. Descendant · cites it directly · 36 of its ownK992872 Branemark Bone-Anchored Hearing Aid (Baha) Cordelle IIEntific Medical Systems, Inc. · 1999

Showing 5 of 50 descendants. See all descendants

Descendants cleared per year

1996: 11999: 32002: 12004: 12005: 12008: 32009: 32010: 12011: 52012: 12013: 42015: 42016: 62017: 12018: 22019: 12021: 52024: 12025: 22026: 4
1996high 6 (2016) · low 0 (1997)2026

Most influential descendants

Showing 5 of 50 · See all
  • K955713Nobelpharma Bone Anchored Hearing AidNobelpharma USA, Inc. · 1996 · cites it directly45descendants
  • K984162Branemark Bone-Anchored Hearing Aid (Baha) System for Pediatric UseNobelpharma USA, Inc. · 1999 · cites it directly43descendants
  • K021837Branenmark Bone-Anchored-Hearing Aid (Baha)Entific Medical Systems, Inc. · 2002 · 2 generations on40descendants
  • K042017Baha DivinoEntific Medical Systems, Inc. · 2004 · 2 generations on39descendants
  • K992872Branemark Bone-Anchored Hearing Aid (Baha) Cordelle IIEntific Medical Systems, Inc. · 1999 · cites it directly36descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K945154BA-CpasNobelpharma USA, Inc.1995—
+1K955713Nobelpharma Bone Anchored Hearing AidNobelpharma USA, Inc.1996—
+1K984162Branemark Bone-Anchored Hearing Aid (Baha) System for Pediatric UseNobelpharma USA, Inc.1999—
+2K021837Branenmark Bone-Anchored-Hearing Aid (Baha)Entific Medical Systems, Inc.2002—
+2K042017Baha DivinoEntific Medical Systems, Inc.2004—
+1K992872Branemark Bone-Anchored Hearing Aid (Baha) Cordelle IIEntific Medical Systems, Inc.1999—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
199930
200210
200410
200510
200830
200930
201010
201150
201210
201340
201540
201660
201710
201820
201910
202150
202410
202520
202640
FIG. 1 — Lineage of K945154, 1995–2026Source: 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 FZE? 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 FZE device

  1. #1 K241253 Medicon Epiplating Systemscore 9.1 · 3 generations · no Class I recall
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? (50)

See all 50

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K955713Nobelpharma Bone Anchored Hearing AidNobelpharma USA, Inc.199645
K984162Branemark Bone-Anchored Hearing Aid (Baha) System for Pediatric UseNobelpharma USA, Inc.199943
K992872Branemark Bone-Anchored Hearing Aid (Baha) Cordelle IIEntific Medical Systems, Inc.199936
K090630Nobel Biocare Endosseous Implants (Maxillofacial Indication)Nobel Biocare AB20092
K990458Straumann Extraoral Implant SystemStraumann USA19992

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, K955713 (Nobelpharma USA, Inc., 1996) has gone furthest, with 45 descendants of its own.

How does its category compare?

All FZE devices

FZE Prosthesis, Nose, Internal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FZE

1in 2024

2007: 12009: 12010: 12016: 12024: 1
2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FZE

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

Recalls per year · FZE

No recall names FZE since 2007.

Adverse event reports per year · FZE

13in 2025

2008: 22016: 72017: 132018: 122019: 242020: 232021: 322022: 302023: 142024: 262025: 13
2007high 32 (2021) · low 0 (2007)2025

MAUDE reports naming product code FZE, 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
20080—02
20091—00
20101—00
20110—00
20120—00
20130—00
20140—00
20150—00
20161—07
20170—013
20180—012
20190—024
20200—023
20210—032
20220—030
20230—014
20241—026
20250—013
20260—0—

More from Nobelpharma USA, Inc.

64 FDA decisions under this applicant name. See the company

  • K984162Branemark Bone-Anchored Hearing Aid (Baha) System for Pediatric UseNobelpharma USA, Inc. · 1999
  • K962403Noblepharma Wide AccessoriesNobelpharma USA, Inc. · 1996
  • K955713Nobelpharma Bone Anchored Hearing AidNobelpharma USA, Inc. · 1996
  • K962130Branemark Systems Mkii Selk-Tapping FixtureNobelpharma USA, Inc. · 1996
  • K96173617 Angulated AbutmentNobelpharma USA, Inc. · 1996

Recent decisions in FZE

The FZE category page

  • K241253Medicon Epiplating SystemCmf Medicon Surgical, Inc. · 2024
  • K161548Osseointegrated FixturesSouthern Implants (Pty), Ltd. · 2016
  • K090803Hanson Medical Facial ImplantsHanson Medical, Inc. · 2010
  • K090630Nobel Biocare Endosseous Implants (Maxillofacial Indication)Nobel Biocare AB · 2009
  • K071018Monarch Nasal ImplantHanson Medical, Inc. · 2007

https://510kreport.com/device/K945154 · printed Nov 4, 2026

Cite this page

510(k) Report. “K945154: BA-Cpas.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K945154

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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