510(k) Report

PMA · Approved

Approved

Telectronics Pasar Model 4171 PG

P850027/S005PMAApproved Feb 2, 199017-day reviewClass III

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

Telectronics, Inc. · LWW Pulse-Generator, Single Chamber, Single

Approved on Feb 2, 1990 through premarket approval, which rests on the device’s own clinical evidence after a 17-day review.

Decided
Feb 2, 1990
Review
17 days
Class
Class III
Product code
LWW
Recalls
None

PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.

FIG. 1 — Lineage of P850027/S005Source: FDA PMA database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LWW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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Does it have a predicate?

PMA decisions do not claim a predicate 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.

How does its category compare?

All LWW devices

LWW Pulse-Generator, Single Chamber, Single: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LWW

2in 2012

2012: 2
2007high 2 (2012) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LWW

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

Recalls per year · LWW

No recall names LWW since 2007.

Adverse event reports per year · LWW

2in 2024

2017: 22018: 12019: 32020: 22021: 22022: 22023: 22024: 2
2007high 3 (2019) · low 0 (2007)2025

MAUDE reports naming product code LWW, 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
20070—00
20080—00
20090—00
20100—00
20110—00
20122—00
20130—00
20140—00
20150—00
20160—00
20170—02
20180—01
20190—03
20200—02
20210—02
20220—02
20230—02
20240—02
20250—00
20260—0—

More from Telectronics, Inc.

113 FDA decisions under this applicant name. See the company

  • P850027/S006Telectronics Pasar Model 4171 PGTelectronics, Inc. · 1990
  • P850027/S003Telectronics Pasar Model 4171 PGTelectronics, Inc. · 1990
  • K890895Implantable Adaptor 033-380Telectronics, Inc. · 1990
  • K891231Optima MPT and SPT PacemakersTelectronics, Inc. · 1989
  • P850027/S002Telectronics Pasar Model 4171 PGTelectronics, Inc. · 1989

Recent decisions in LWW

The LWW category page

https://510kreport.com/device/P850027/S005 · printed Nov 6, 2026

Cite this page

510(k) Report. “P850027/S005: Telectronics Pasar Model 4171 PG.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P850027/S005

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026